Medical blog » Lilly

FDA: 'Mistake' Not To Include Doctor At Eli Lilly Drug Panel

admin — Thu, 29 Jan 2009 15:42:19 +0000

-(Dow Jones)- U.S. federal regulators on Monday acknowledged it was
a mistake to “dis-invite” a leading cardiologist to a panel that was deciding
whether to recommend approval for a controversial anti-clotting drug made by
Eli
Lilly & Co.
(LLY).
Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Heart Institute in
, was scheduled to participate in a
Feb. 3
Prasugrel, an anti-clotting drug that has been linked
to dangerous internal bleeding.
Panel members at the meeting voted 9 to 0 to recommend approval of the drug.
Several days before the meeting, FDA managers received a call from
saying it had questions about Kaul’s inclusion in the meeting because he had
authored several papers that were critical of Prasugrel, FDA officials said.
representatives weren’t immediately available to comment. This news was
first reported by the blog HeartWire.
Under federal regulation, the FDA can exclude members from participating in a
meeting if they have a financial conflict of interest, such as having received
consulting fees from a company, or for “intellectual bias.” Determining
intellectual bias, or whether someone has already made their mind up about
whether a drug should be on the market, is difficult, and FDA officials say a
series of errors lead to Kaul’s exclusion from the meeting.
FDA managers that screen panel members only asked Kaul about his financial
conflicts of interest, of which he had none, not about any intellectual bias,
said Dr.
, director of the FDA’s drug division.
for the
meeting.
“At every step of the way there were errors by multiple parties,” Woodcock
said.
The FDA hasn’t done a formal review to determine whether Kaul was actually
intellectually biased, but one FDA official said he would have welcomed the
cardiologist’s input at the meeting.
“In my own personal opinion I didn’t see anything in [Kaul's] writings…that
would preclude him from serving on the committee,” said
, FDA’s
director of the Office of New Drugs. “I think he would have been a very valuable
member.”
To be sure, FDA officials described the discussion at the meeting as robust
and don’t think the kerfuffle invalidates the results of the panel.
Prasugrel isn’t on the market yet, and it’s unclear when the FDA will make a
decision about whether to approve it. The drug, co-marketed by
Daiichi Sankyo Co.
(4568.TO), is expected to bring in ample sales for
the companies.
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@
dowjones.com
(END) Dow Jones Newswires
02-23-09 1807ET
Copyright (c) 2009 Dow Jones & Company, Inc.

FDA Panel Assesses Lilly Blood Thinner

admin — Sun, 07 Dec 2008 07:27:01 +0000

For the last six years,
’s blood thinner Plavix has enjoyed a near monopoly in the market for oral medications meant to prevent clots in patients who are at risk for heart attacks and strokes.
That monopoly status could be threatened, if the
. Tuesday afternoon, an advisory panel may recommend that the F.D.A. grant that approval.
Plavix had global sales of $7.3 billion in 2007, making it the world’s second best-selling drug after
, according to sales data compiled by
, a health-care information company.
Last year Plavix, which Bristol-Myers markets in a partnership with
, had about $4.8 billion in U.S. sales — representing 92.5 percent of the domestic market for such drugs, IMS said.
But now Lilly means to challenge Plavix as the standard of care for patients who develop sudden blood clots inside a coronary artery, a problem called acute coronary syndrome.
The Lilly drug, prasugrel, was on the agenda of a day-long hearing Tuesday by an F.D.A. advisory panel, which has been widely expected to recommend it be approved as a treatment for patients with acute coronary syndrome who are undergoing surgery for coronary artery repair. The F.D.A. typically, but not always, follows such recommendations.
The drug, which Lilly plans to market the under the brand name Effient, is not without risks. Earlier Tuesday, an F.D.A. cardiologist told the panel of outside experts meeting in Silver Spring, Md., that Prasugrel comes with a tradeoff of higher potential hazards along with its increased effectiveness.
Prasugrel reaches its maximum anti-coagulant effect more quickly than does clopidogrel, the drug ingredient in Plavix, said Dr. Ellis F. Unger, the deputy director of the division of cardiovascular and renal drugs products at the F.D.A.’s Center for Drug Evaluation and Research.
But prasugrel also significantly increases the risk of bleeding, according to a study in which about 13,600 people were randomly assigned to take the new drug or clopidogrel. The study, published in the
in 2007, was funded by Lilly and Daiichi Sankyo, the co-developer of the drug.
For every 1000 patients treated with prasugrel instead of clopidogrel, there would be three fewer cardiac-related deaths and 21 fewer non-fatal heart attacks, Dr. Unger told the panel.
But he said there would also be drawbacks: two additional deaths caused by bleeding, three more incidents of the kind of serious bleeding that required medical intervention and five cases of minor bleeding.
Among the prasugrel group in the study, there was a higher incidence of bleeding among people who had previously had strokes, people age 75 or older, and people who weighed less than 132 pounds. Because of those findings, industry analysts predicted that the agency would restrict the use of the new drug to people younger than 75 who have never had a
.
“Unfortunately for Lilly, they are going to limit prescribing on prasugrel,” said David S. Moskowitz, an analyst at Carin & Company. “It will have a narrower use. But for those patients, it will have superior results.”
. Although Dr. Unger told the panel that the agency did not believe the drug caused cancer, industry analysts said labels for the new drug were likely to include a warning of a potential cancer risk.
Analysts offered conservative sales projections for the new drug which, if approved, is expected to go on sale later this year. In his note to investors on Monday, Steve Scala, an analyst with Cowen and Company, estimated sales of prasugrel at $150 million for in 2009 and $1.5 billion by 2015.
Chris Schott, an analyst at
, had lower estimates: $10 million for this year, $825 million by 2013. “You need much clearer side effect profile and labeling to get the broad adoption you have with Plavix,” Mr. Schott said.
The potential advent of prasugrel comes at a time when the F.D.A. is investigating concerns about Plavix’s effectiveness among some types of patients.
Last week, the agency issued an
saying it was examining studies from medical journals that reported either that the drug may not work in patients with certain genetic mutations or that certain acid-reflux drugs, called proton pump inhibitors, may reduce the drug’s efficacy. Such acid-reflux drugs include Nexium and Prilosec. Meanwhile, the agency recommended patients on Plavix continue to take it.
During an earnings call last week, executives at Bristol-Myers recommended that cardiologists whose patients take Plavix consider prescribing a different kind of acid-reflux medication.
Despite the questions raised about Plavix, some cardiologists who have used that drug for years said they would proceed cautiously on Lilly’s prasugrel. “The significant reduction in cardiac events was mitigated by the increase in bleeding,” said Dr. Rajiv Jauhar, the director of interventional cardiology at Long Island Jewish Medical Center in New Hyde Park, N.Y.. Once doctors prescribe the drug to a large number of patients outside the controlled environment of a clinical trial, serious bleeding might occur more frequently, he said. Dr. Jauhar, who has occasionally lectured on Plavix for Bristol-Myers, said he was taking a wait-and-see position.
“I am hesitant until I have more data about the use of prasugrel,” Dr. Jauhar said.

Lilly Sees Slower 2009 Sales Growth, Big 4Q Charge

admin — Fri, 28 Nov 2008 22:21:16 +0000

(Adds analyst reaction beginning in seventh paragraph and updated stock
price.)
Eli Lilly & Co.
(LLY) expects to swing to a profit in
2009 from an anticipated loss in 2008 but sees sales growth slowing due to less
favorable currency exchange rates as well as generic competition for one of its
cancer drugs.
$6.5 billion
acquisition of ImClone Systems would result in a large charge for the fourth
quarter, causing the full-year net loss. The company also expects costs from the
deal to reduce 2009 earnings.
But excluding these financial impacts of ImClone in both years, and other
items, Lilly sees 2009 earnings growth of 8% to 15% from 2008.
. In addition, Lilly
highlighted what it considers to be a stronger pipeline of experimental drugs
partly as a result of the ImClone acquisition, which expanded Lilly’s presence
in cancer drugs.
Bristol-Myers Squibb Co.
(BMY) to win ImClone, which developed
the cancer drug Erbitux, and Lilly sees the deal as crucial to getting through a
challenging period of new generic competition for top drugs including
antipsychotic Zyprexa beginning around 2011.
, or 2.7%, to
$35.95
.
Some analysts said Lilly appeared to taking the right steps to get ready for
the wave of patent expirations it will hit in the next few years. But Lilly’s
ability to perform well in that period will depend upon whether drugs currently
in development will be approved and be successful – a somewhat risky proposition
given the cautious stance over drug safety taken by the U.S. Food and Drug
Administration.
“They have a good foundation right now for decent adjusted earnings growth in
2009,” said
, analyst with BMO Capital Markets, who rates Lilly
shares “outperform.” “The message here is let’s prepare for the next decade.”
Lilly’s leaders also indicated Thursday that they would consider entering the
so-called “follow-on biologics” market, in the wake of
Merck & Co.’s
(MRK)
disclosure this week that it was jumping into that field. Follow-on biologics
are loosely equivalent to generic versions of biotechnology-style drugs and are
seen as a future growth area for the drug industry. Lilly said it hadn’t firmed
its plans, but the recent ImClone buy has beefed up Lilly’s biotech
capabilities, and executives say it’s a possible strategic move.
“We’re very much considering that,” Chief Executive
told
analysts during a conference call. “We’ve not explicitly stated that as part of
our overall strategy in biotech.”
For 2008, Lilly expects to post a net loss of
$1.56 to $2.06
a share, revising
its earlier forecast of earnings of
$2.44 to $2.49
a share. The main factor is
an anticipated charge of
$4.05 to $4.50
a share related to the ImClone deal,
which closed in November. Excluding the charge and other items, Lilly sees 2008
earnings of
$3.97 to $4.02
a share, in line with its previous forecast excluding
items and up 12% to 14% from 2007.
The 2008 results are expected to reflect sales growth in the high single-
digits to low-double-digits on a percentage basis. But 2009 sales growth is seen
slowing to the low single digits because the U.S. dollar has strengthened
against foreign currencies. Also, cancer drug Gemzar is expected to face generic
competition outside the U.S. Gemzar had sales of
$1.6 billion
in 2007. (The
stronger dollar, however, also is expected to improve gross profit margins,
particularly in the first half of 2009).
On average, analysts surveyed by Thomson Reuters were anticipating 2009 sales
growth of 7% to
. CEO Lechleiter said an added uncertainty for 2009
is the possibility of health-care reform by the incoming Obama administration.
He expressed hope that reform measures wouldn’t be “carried out on the back of
the biopharma industry.”
Another challenge to sales growth may come from people trimming health-care
expenses due to the economic downturn. But Chief Financial Officer Derica Rice
told Dow Jones Newswires several drugs were continuing to post sales growth
because they treat diseases or conditions where symptoms would worsen
immediately if treatment stopped, such as insulin for diabetics. Even sales of
impotence drug Cialis were still growing, he noted.
$4 to $4.25
a share. This
reflects costs from the ImClone Systems purchase, which are seen reducing
earnings by
a share. Excluding these, earnings would be
$4.35 to
$4.55
a share, up 8% to 15% from expected 2008 results.
Although some analysts were expecting the earnings dilution from the ImClone
purchase to be lower, Rice said the impact was actually better than Lilly had
expected going into the acquisition. He said the dilution reflects the
amortization of intangible assets, cost of financing and ongoing support of
ImClone’s drug research. Rice added that some analysts didn’t include ongoing
research costs in their models.
Lilly’s 2009 forecast assumes the launch of prasugrel, the anti-clotting drug
codeveloped with
(4568.TO) that analysts think could be a big
seller. Lilly had hoped for regulatory approval by the end of this year, but the
Food and Drug Administration has missed its targeted decision date, and Lilly is
still in talks with the FDA on the application. A large study showed prasugrel
was more effective than market leader Plavix – co-marketed by
Bristol-Myers
Squibb Co.
(SNY) – at reducing risk of heart attacks
and related disease, but it increased the risk of major bleeding.
Lilly is studying several other experimental drugs in late-stage trials that
the company hopes will come to market in coming years, including treatments for
Alzheimer’s disease, diabetes and osteoporosis. Lilly said it planned to reduce
the cost of bringing a new drug to market to an average of
$1.2 billion
now.
Lilly’s forecast for both years assumes continued strong growth in sales of
the antidepressant Cymbalta, which has been approved for additional uses such as
the pain condition fibromyalgia. Sales could get a further boost because the
giant health insurer
WellPoint Inc.
(WLP) has moved the drug up on its
formulary, or list of preferred drugs, so that its members have better coverage
for the drug, Rice disclosed.
Lilly also expects continued sales growth for the impotence drug Cialis,
cancer drug Alimta and diabetes drug Humalog.
Separately, asked to address the prospect of industry consolidation,
Lechleiter said Lilly planned to remain independent and he said mega-mergers in
the drug industry haven’t been very successful.
, Dow Jones Newswires; 215-656-8289;
Kerry E. Grace
contributed to this report.)
Click here to go to Dow Jones NewsPlus, a web front page of today’s most
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. You can use this link on
the day this article is published and the following day.
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FDA Reviewing Safety Of Lilly Sepsis Drug Xigris

admin — Thu, 27 Nov 2008 19:17:13 +0000

Eli Lilly & Co.
(LLY) drug used to treat severe sepsis after
a recent study suggested the drug could increase the risk of serious bleeding
and death.
In a so-called “early communication” posted Wednesday on the FDA’s Web site,
the agency said it was working with Lilly “to further evaluate the incidence of
serious bleeding events and mortality in patients who received Xigris.”
Sepsis is a potentially life-threatening condition that occurs when an
infection spreads throughout the bloodstream. Xigris is used to treat adults
with severe cases of sepsis who are at high risk of death. Xigris already
carries warnings that it could increase the risk of bleeding and death in
certain patients and recommends the drug not be used by such patients as those
who have had a recent severe head injury.
The FDA said the study, which was published last month in the journal Critical
Care Medicine, involved a review of 73 patients who received Xigris. Serious
bleeding events occurred in seven of 20 patients, or 35%, who were considered at
risk of having bleeding problems, compared to two out of 53, or 3.8%, who didn’t
have underlying factors that would increase bleeding risk, according to the
study. The study also showed more patients with bleeding risks died.
The FDA said the study findings are consistent with the information in the
current product label and recommended doctors prescribing the drug “carefully
weigh the increased risk of bleeding against the benefits of Xigris.”
The FDA said its review of Xigris may take several months.
, Dow Jones Newswires; 202-862-9294;
(END) Dow Jones Newswires
02-04-09 1031ET
Copyright (c) 2009 Dow Jones & Company, Inc.

Lilly Blood Thinner Gets FDA Panel Nod

admin — Sat, 15 Nov 2008 12:51:27 +0000

rose into the close Tuesday after an FDA unanimously recommended approval of its anticlotting agent prasugrel.
The nine members of the Food and Drug Administration’s cardiology panel said the new blood thinner, which Lilly developed with Japanese drugmaker
, is a significant improvement over its forebears for preventing blood clots in patients with heart problems.
Lilly had asked the panel to specifically evaluate prasugrel in patients requiring stents after arterial plaque removal.
Lilly shares closed up 3.8% to $38.69 and were tacking on an additional 1.1% in extended trading Tuesday.

FDA: Eli Lilly blood thinner has clear benefits

admin — Wed, 05 Nov 2008 21:14:22 +0000

WASHINGTON (AP) — Federal health officials said Friday a blood thinner from Eli Lilly offers life-saving benefits over drugs currently on the market, though its use may have to be restricted due to bleeding side effects.
The Food and Drug Administration is reviewing the highly anticipated drug, called prasugrel, as a therapy for patients with acute heart problems such as heart attacks, who face increased risk of blood clots. Lilly developed the drug with Japanese drugmaker Daiichi Sankyo.
In a 357-page review posted online, FDA reviewers said the drug’s effectiveness over the leading blood thinner Plavix “seems beyond question.” Plavix, the second-best-selling prescription medicine in the world, is made by Bristol-Myers Squibb and Sanofi-Aventis. Like Plavix, pragrusel works by stopping components of blood, called platelets, from sticking together and clotting.
Regulators have delayed making a decision on prasugrel twice since it was submitted last January. The drug’s approval is considered key for Lilly’s financial outlook, as the patent on its best-selling drug, the anti-psychotic Zyprexa, is due to expire in two years.
Analysts have attributed much of the delay to prasugrel’s unusual safety profile: while it clearly reduces life-threatening heart problems, it also increases risk of internal bleeding.
Next week the agency will ask a panel of outside cardiology experts to assess the drug’s risks and benefits. The experts will also weigh in on whether prasugrel should not be prescribed to some patients, such as those with a history of stroke, because of its bleeding risks.
The FDA typically follows its experts’ advice, though agency reviewers already backed approval for the drug in their assessment Friday, saying its lifesaving benefits outweigh its side effects.
Data from a 12-month study reviewed by FDA showed that for every 24 serious heart problems the drug prevented, it caused 10 bleeding side effects. Overall, reviewers concluded that prasugrel was associated with three fewer heart-related deaths than Plavix.
“The division believes that this is a worthwhile risk-benefit profile for patients who might receive prasugrel,” the agency states.
Reviewers also mentioned increased rates of cancer seen in patients taking prasugrel, compared with Plavix. However, the agency notes that the drug’s internal bleeding side effect may have simply led to more medical exams and higher detection of existing cancers.
Indianapolis-based Lilly made this point in its own briefing documents posted Friday.
“We feel like we’ve investigated this issue very carefully, and there’s no scientific evidence that prasugrel causes new cancer or makes an existing cancer worse,” Eli Lilly Vice President Dr. Anthony Ware said in an interview earlier this week.
The FDA said doctors should be alerted to the cancer trends, and some reviewers recommended a “black box” warning about the concerns.
The possibility of a boxed warning, the most serious a drug can bear, took some analysts by surprise, considering the mostly positive tone of the FDA’s review.
“While this is a positive for Lilly shares relative to our bearish stance, it does set the product up for a difficult launch,” Natixis Bleichroeder analyst Jon Lecroy wrote in a note to investors.
The agency plans to ask its outside adviser whether prasugrel’s bleeding side effects could be minimized by restricting use in certain patients.
Lilly seemed to anticipate these concerns in its own documents.
The company suggests not prescribing the drug for patients with a history of stroke or ongoing internal bleeding. Lilly also recomends labeling that would caution doctors about prescribing the drug to patients who are older than 75 or who weigh less than 132 pounds.
Those restrictions would give prasugrel a narrower pool of users than Plavix.
In a separate development Friday, Lilly formally pleaded guilty to a misdemeanor tied to the marketing of its top-seller, the anti-psychotic Zyprexa.
Lilly agreed to the plea earlier this month and will pay about $800 million to resolve a civil case tied to the drug’s marketing. Prosecutors allege Lilly marketed Zyprexa for unapproved uses, including Alzheimer’s-related dementia.
Share of Eli Lilly fell $1.15, or 3 percent, to close at $36.82.

FDA: Eli Lilly blood thinner has clear benefits

admin — Sun, 05 Oct 2008 07:20:32 +0000

Published: February 02. 2009 12:01AM
WASHINGTON — Federal health officials said Friday a blood thinner from Eli Lilly offers lifesaving benefits over drugs currently on the market, though its use may have to be restricted due to bleeding side effects.
The Food and Drug Administration is reviewing the highly anticipated drug, called prasugrel, as a therapy for patients with acute heart problems such as heart attacks, who face increased risk of blood clots. Lilly developed the drug with Japanese drugmaker Daiichi Sankyo.
In a 357-page review posted online, FDA reviewers said the drug’s effectiveness over the leading blood thinner Plavix “seems beyond question.” Plavix, the second-best-selling prescription medicine in the world, is made by Bristol-Myers Squibb and Sanofi-Aventis.
Like Plavix, pragrusel works by stopping components of blood, called platelets, from sticking together and clotting.
WASHINGTON — Call it the cold case file of drug safety.
Federal health officials convened a public hearing Friday on whether to ban Darvon, a painkiller first approved in 1957, when there were few alternatives for treating pain except aspirin and powerful narcotics.
Now mainly marketed as Darvocet, which includes a dose of acetaminophen, the drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.
The consumer group Public Citizen said the FDA should withdraw Darvon from the market because the drug offers relatively weak pain relief and poses an overdose risk, with the potential to be used in suicides.
NEW YORK — A federal appeals court says lawsuits brought by Nigerian families against Pfizer over the drugmaker’s testing of an antibiotic to treat meningitis can go forward.
The 2nd U.S. Circuit Court of Appeals in New York on Friday restored two lawsuits that had been tossed out by a lower court judge.
The appeals court said it seemed proper to bring the lawsuits in the United States.
The lawsuits sought unspecified damages on behalf of children who were part of a study of the oral antibiotic.
Pa. dairies recall ice cream due to peanut risk
JOHNSTOWN — Two Pennsylvania dairies are voluntarily recalling some ice cream and frozen yogurt flavors because of a possible link to salmonella-tainted peanuts.
The recalls announced Friday by Galliker Dairy in Johnstown and Turkey Hill in Lancaster County are because the Peanut Corporation of America expanded its recall.
Turkey Hill is recalling six flavors: Tin Roof Sundae Premium, Chocolate Nutty Moose Tracks Stuff’d, Chocolate Nutty Moose Tracks Light Recipe, Nutty Caramel Caribou Frozen Yogurt, Peanut Brittle No Sugar Added Recipe and Peanut Butter Mania Light Recipe.
Galliker is recalling Rocky Road Ice Cream and Sundae Nut Cones.
Only certain date codes are affected. Consumers with questions can call Turkey Hill at 800-693-2479 and Galliker at 800-477-6455 Ext. 239.
See this story as it was printed in Erie Times-News’ electronic edition.
.
This content provided by GoErie.com/Erie Times-News is copyrighted material and all rights are reserved. You may not reproduce this or distribute it electronically, in print or otherwise without written permission.

Eli Lilly faces FDA delay on schizophrenia drug

admin — Tue, 16 Sep 2008 07:54:16 +0000

Eli Lilly & Co. said Wednesday the Food and Drug Administration is withholding approval on the long-acting version of schizophrenia treatment olanzapine.
The FDA is not requiring additional studies and the company said it is preparing a risk evaluation and mitigation strategy, to be submitted in the near future.
“We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness,” said Dr. Todd Durell, associate medical director for U.S. neuroscience at Eli Lilly.
The long-acting version of olanzapine is already approved in the European Union and New Zealand under the name Zypadhera.
Shares of Eli Lilly fell 33 cents to $38.29 in morning trading.
Copyright 2008 Associated Press. All rights reserved. This material may not be published broadcast, rewritten, or redistributed

Lilly Receives NCQA Health Information Product Certification for …

admin — Sun, 14 Sep 2008 01:17:19 +0000

,
Nov. 24
) Health
Education Answers, an interactive online program, has received Health
Information Product Certification from the National Committee for Quality
Assurance (NCQA) for the Health Risk Appraisals and Interactive Consumer
Health Tools certification options. NCQA is a private, non-profit organization
dedicated to providing health care quality information through the Web and the
media in order to help consumers, employers, and others make more informed
health care choices.
“Earning NCQA’s Health Information Product Certification demonstrates that
an organization has expertise in gathering and disseminating health care
information for patients,” said
Kathleen C. Mudd
, vice president, Product
Delivery, NCQA. “Lilly is to be commended for being the first pharmaceutical
company in the nation to be reviewed for these services.”
Health Education Answers is a Web-based program designed for managed care
and public payer organizations to assist in further driving the standard of
patient care through interactive educational information. Patients accessing
the program can progress through an entire neighborhood of health education
and disease management modules, including: ADHD, Bipolar Disorder, Depression,
Diabetes, Diabetes Complications, Manage Your Weight, Medication Safety, Men’s
Health, Schizophrenia, Smoking & Addictions, and Women’s Health.
Available in English and Spanish with full audio, the Health Education
Answers program includes research-supported patient education material that
adheres to national clinical guidelines. This tool educates patients on
several health areas, including proper diet and exercise, healthy habits to
teach their kids, and simple steps to help themselves and their families
prevent illness.
Health Education Answers also includes an optional health risk assessment
that helps patients identify and understand their individual health needs and
at-risk behaviors and suggestions for improvement. Based on the results,
Health Education Answers then directs patients to the most applicable
education modules.
“The Health Education Answers program is another example of Lilly’s
commitment to going beyond medicine to support the overall health needs of
patients,” said
, vice president, Lilly. “Receiving HIP
certification is especially important to us because it is an external
validation from an independent team of health care professionals that this
intervention meets rigorous quality standards.”
Programs such as Health Education Answers improve health and wellness
while reducing health care costs for payers and their patients. According to a
report released by the Trust for America’s Health, researchers indicate that
preventive measures will reduce the cost of health care, estimating that for
an annual investment of
in a “proven” community prevention program, the
return on investment in 10 to 20 years will exceed
for every dollar
invested.(i)
Lilly also offers three Disease Management programs with NCQA Program
Design Certification as part of its ongoing commitment to improving the
standard of patient care. They include:
— Tools That Empower(TM) Depression Care Management Program — A program
designed for managed care organizations to assist in further driving the
standard of patient care around Major Depressive Disorder.
— Tools That Empower(TM) Diabetes Management Program — A robust diabetes
disease management program that contains more than 20 best-in-class tools and
resources for care managers and diabetes program directors.
— HealthInsights for Women — A disease management program designed for
women aged 30 years and older that provides information about disease risk
factors and encourages them to make behavior changes that can lead to better
health.
For more information about Lilly’s disease management and health education
programs, visit Lilly.com and LillyforBetterHealth.com
NCQA is a private, nonprofit organization dedicated to improving health
care quality. NCQA is committed to providing health care quality information
through the Web and the media in order to help consumers, employers and others
make more informed health care choices.
, or by calling NCQA Customer Support at
(888) 275-7585.
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind.
, Lilly provides answers — through medicines and
information — for some of the world’s most urgent medical needs. Additional
information about Lilly is available at
.
(i) Trust for America’s Health, Blueprint for a Healthier America:
Modernizing The Federal Public Health System To Focus On Prevention And
Preparedness,
Washington, DC
: Trust for America’s Health,
.
Nov. 4,
2008
).

Lilly CEO: FDA's Prasugrel Review Is 'Very Far Along'

admin — Sun, 31 Aug 2008 19:33:56 +0000

U.S. regulators are “very far along” in their review of
Eli Lilly & Co.’s
(
LLY) application to market an experimental anti-clotting drug, prasugrel, Chief
Executive
said Thursday.
But Lechleiter, during on a conference call with analysts Thursday, didn’t
provide any more specific projection of when the Food and Drug Administration
might make a decision.
Sept. 26
, but that the review was very far
along. Analysts believe prasugrel could eventually become a big seller.
Last week, Lilly,
, said it continued to have discussions with the
FDA regarding the application, and that it hadn’t been notified of an agency
decision to hold an advisory committee meeting to review the drug. Published
reports said the FDA might hold such a meeting in February, which would mean
approval would be unlikely before then.
Lechleiter addressed the uncertainty Thursday, saying “yes, the review is very
far along.” Lilly still doesn’t know whether the FDA plans to hold an advisory
committee meeting.
“We continue to work productively with the agency in our continuing efforts to
gain approval for this product,” Lechleiter said.
Analysts have suspected prasugrel would be an ideal topic for a panel of
outside advisors because, although a study showed it was more effective than the
drug Plavix at reducing risk of heart problems, it also increased the risk of
serious bleeding events. Plavix is co-marketed by
Bristol-Myers Squibb Co.
(SNY).
Lilly has said the bleeding risk was largely confined to certain patient
populations such as the elderly and those light in weight, and it is possible
the FDA-approved label for the drug would restrict its use in these patient
groups.
, Dow Jones Newswires; 215-656-8289;
Click here to go to Dow Jones NewsPlus, a web front page of today’s most
important business and market news, analysis and commentary: http://
. You can use this link
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