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Medtronic wins FDA approval for Reclaim brain stimulation therapy

admin — Tue, 20 Jan 2009 15:58:12 +0000

Feb 23, 2009 (Datamonitor via COMTEX) –
— Medtronic, a medical technology company, has received approval from the FDA for a humanitarian device exemption for its Reclaim deep brain stimulation therapy for chronic, severe obsessive-compulsive disorder.
The company also announced the first enrollment in its multi-center, randomized clinical trial of deep brain stimulation (DBS) for treatment-resistant depression.
Medtronic is proceeding with the FDA investigational device exemption approval for five centers to enroll patients in the clinical trial of DBS for treatment-resistant depression throughout the US, including the Cleveland Clinic, which was the first to enroll a patient in the trial.
According to the company, Reclaim DBS is the first medical device to receive the FDA’s approval for the treatment of obsessive-compulsive disorder (OCD) and is also the first psychiatric indication to be approved for DBS.
Ali Rezai, neurosurgeon at Cleveland Clinic and investigator in early studies of DBS for OCD, said: “For patients with OCD, DBS therapy represents an alternative therapeutic approach, which may be an option for patients who did not experience a benefit from more traditional treatments. The clinical trial of DBS in treatment-resistant depression is an important step in understanding this therapeutic approach for patients with severe depression.”

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J&J seeks full FDA approval for HIV treatment

admin — Wed, 07 Jan 2009 00:16:46 +0000

WASHINGTON (AP) — A division of Johnson & Johnson has asked federal regulators to grant full approval to an HIV drug designed to treat patients who have stopped responding to other treatments.
The Food and Drug Administration gave Intelence preliminary approval in January under its accelerated approval program, which allowed J&J to market the drug. In order to gain full approval, FDA required the company to submit follow-up data on the drug’s effectiveness.
Data submitted by J&J’s Tibotec unit showed that 60 percent of patients taking the drug for four months had undetectable levels of HIV in their blood compared with 39 percent of patients taking a placebo.
Intelence is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, that blocks the enzyme HIV needs to multiply.
Tibotec Therapeutics is a division of Ortho Biotech Products, L.P., a Johnson & Johnson company based in Bridgewater, N.J.
Shares of Johnson & Johnson rose 15 cents to $58.11.

Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) for …

admin — Sun, 04 Jan 2009 04:53:45 +0000

KING OF PRUSSIA, Pa.
,
Jan. 5
/PRNewswire/ — Prism Pharmaceuticals
announced today that the U.S. Food & Drug Administration (FDA) has approved
the new drug application (NDA) for NEXTERONE(R) (amiodarone HCl) Injection, a
novel, patent-protected, cosolvent free formulation of the antiarrhythmic
agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone(R)
Intravenous. NEXTERONE is indicated for the treatment and prophylaxis of
frequently recurring ventricular fibrillation and hemodynamically unstable
ventricular tachycardia in patients refractory to other therapy.
“Approval of our first product is an important corporate milestone and
validates our accelerated development model, which allowed us to move
NEXTERONE from licensing to FDA clearance in less than three years and ahead
of the PDUFA target date,” said Dr.
Warren D. Cooper
, President and CEO of
Prism. “We developed NEXTERONE to overcome solvent-based limitations of
conventional intravenous amiodarone and to improve patient care and overall
medication management in the setting of life-threatening cardiac arrhythmias.”
NEXTERONE represents the first product to successfully overcome the long
recognized solubility issues of amiodarone by removing the original cosolvents
polysorbate 80 and benzyl alcohol. As a result of removing these cosolvents,
NEXTERONE does not have many of the product administration limitations
regarding compatibility and stability with plastics and ionic infusion fluids,
which are included in the labeling of conventional intravenous amiodarone.
Importantly, NEXTERONE does not carry the specific warning about the risk of
fatal gasping syndrome in newborn infants because it does not contain benzyl
alcohol.
Improving medication safety in the hospital environment is an area of
significant and current attention. This agenda is being driven by entities
such as The Joint Commission, which is responsible for the accreditation of
hospitals, and the Institute for Safe Medication Practices. Providing
injectable products, especially those for critical care use, in premixed,
ready to use forms is a high priority solution to minimize medication errors.
Dr. Cooper continued, “While this regulatory approval is for NEXTERONE
supplied in vials and a prefilled syringe, the changes in the compatibility
and stability profile of NEXTERONE, brought about by the removal of
polysorbate 80 and benzyl alcohol, present the opportunity to formulate
intravenous amiodarone for the first time in premixed, ready to use
configurations.”
Prism is currently implementing a full scale manufacturing development
program with the Medication Delivery business of Baxter Healthcare
Corporation, a world leader in premix technologies. Prism intends to submit a
supplemental NDA for the premixed configurations which will form the focus of
the commercial launch of NEXTERONE as a complete product line. Health-System
Pharmacists hold the primary management responsibility for improvements in
medication safety in hospitals and this will be a key target customer group
for NEXTERONE.
“We intend to commercialize NEXTERONE ourselves in the US with partners
that are well positioned in the hospital marketplace and will seek to license
the ex-US worldwide rights,” said Dr. Cooper. “As we round out the NEXTERONE
product line with the premixed bag configurations, we are concurrently
defining the best approach to launch the brand, drive rapid conversion and
optimize the value of NEXTERONE to pharmacists, clinicians, patients and the
Company. I believe NEXTERONE can rapidly replace generic Amiodarone IV when
it becomes available and has the potential to eventually render conventional
Amiodarone IV obsolete.”
milestone payment
from Paul Capital. This long range financing agreement, established in
, provides Prism with non-dilutive capital to enable the company
to bring NEXTERONE through the period of NDA review and commercial launch.
Dr. Cooper will present the corporate strategy for PRISM Pharmaceuticals,
the commercial plans for NEXTERONE and the product pipeline at the 27th Annual
JP Morgan Healthcare Conference on
January 13, 2009
7:30 a.m. PST
10:30
a.m. EST
. A webcast of the presentation will be available on
.
Ventricular fibrillation is a condition in which the heart’s electrical
activity becomes disordered. When this happens, the heart’s lower (pumping)
chambers contract in a rapid, unsynchronized way. (The ventricles “flutter”
rather than beat.) The heart pumps little or no blood. Ventricular
fibrillation is very serious. Collapse and sudden cardiac death will follow in
minutes unless medical help is provided immediately.
Ventricular tachycardia is a fast or rapid heart rate that starts in the
heart’s lower chambers (ventricles). Ventricular tachycardia may result from
serious heart disease and usually requires prompt treatment.
The most important treatment-emergent adverse effects associated with
intravenous amiodarone therapy in clinical studies were hypotension,
asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenic
shock, congestive heart failure, bradycardia, liver function test
abnormalities, ventricular tachycardia, and atrioventricular block. Overall,
treatment was discontinued for about 9 percent of the patients because of
adverse effects. The most common adverse effects leading to discontinuation
of intravenous amiodarone therapy were hypotension (1.6 percent),
asystole/cardiac arrest/EMD (1.2 percent), ventricular tachycardia (1.1
percent), and cardiogenic shock (1 percent).
NEXTERONE is contraindicated in patients with known hypersensitivity to
any of the components of NEXTERONE, including iodine, or in patients with
cardiogenic shock, marked sinus bradycardia, and second- or third-degree AV
block unless a functioning pacemaker is available.
NEXTERONE is for hospital use only. NEXTERONE should be administered only
by physicians who are experienced in the treatment of life-threatening
arrhythmias, who are thoroughly familiar with the risks and benefits of
intravenous amiodarone therapy, and who have access to facilities adequate for
monitoring the effectiveness and side effects of treatment.
For more information about NEXTERONE, including full prescribing
information, visit
.
Prism Pharmaceuticals, based in
King of Prussia, Pennsylvania
, is a
specialty pharmaceutical company committed to developing and commercializing
acute care cardiovascular products. The product portfolio strategy is focused
on recognizing unfulfilled opportunities in existing compounds that address
current unmet medical needs with a specific focus on medication safety in the
hospital environment.
). In 2006 Prism secured a
). This level of sustaining
investment has enabled Prism to pursue an aggressive licensing and rapid
development model resulting in the successful approval of NEXTERONE.
). NEXTERONE is based on the CyDex
patent-protected CAPTISOL(R) technology platform. Prism and CyDex are also
developing a novel injectable form of the blockbuster antiplatelet agent
PLAVIX(R) (clopidogrel) for use in acute care situations overcoming the
limitations of the current product which is only available as an oral therapy.
For further information, visit
.
NEXTERONE(R) is a registered trademark of Prism Pharmaceuticals, Inc.
Cordarone(R) and PLAVIX(R) are registered trademarks of sanofi-aventis.

Biosense wins FDA approval for Navistar Thermocool catheter

admin — Thu, 25 Dec 2008 07:12:20 +0000

The FDA approval is based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of atrial fibrillation (AFib). In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug therapy for the treatment of drug refractory recurrent symptomatic paroxysmal AFib.
The approval by the FDA also includes the EZ Steer Thermocool navigational catheter, which is a bi-directional version of the catheter. These catheters are compatible with 3-D mapping systems which recognize the Carto system magnetic location sensors. These include the Carto, Carto XP, and Carto 3 EP Navigation Systems, the company said.
The Navistar Thermocool catheter is also approved in the US for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction.
Marcia Yaross, vice president of clinical, regulatory and health policy at Biosense Webster, said: “This decision by the FDA recognizes the safety and effectiveness of Navistar Thermocool catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy.”

Novartis wins FDA approval for new indication of Gleevec

admin — Tue, 16 Dec 2008 02:14:33 +0000

Dec 23, 2008 (Datamonitor via COMTEX) –
— Novartis has announced that its Gleevec tablets have received approval from the FDA for the post-surgery treatment of adult patients following complete surgical removal of Kit-positive gastrointestinal stromal tumors.
According to the company, Gleevec is now the only post-surgery treatment indicated to delay the return of this highly aggressive cancer, filling a major need for gastrointestinal stromal tumors (GIST) patients. The filing received the FDA priority review status in August 2008, with regulatory reviews currently underway in other regions, including the EU and Switzerland.
The approval for this new indication is based on data from a National Cancer Institute-sponsored Phase III study that showed a reduction in the return of GIST after surgery in patients treated for about one year with Gleevec versus placebo. Based on a 14-month median follow up, 91.6% of Gleevec patients remained cancer-free compared with 80.2% of those taking placebo, the company said.
Gleevec is now approved for nine indications, including the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), Kit (CD117)-positive GIST which cannot be surgically removed or have already spread to other parts of the body (metastasized) and five other rare diseases.
David Epstein, president and CEO of Novartis Oncology, said: “When Gleevec was first approved for the treatment of inoperable or metastasized Kit-positive GIST six years ago, it revolutionized the treatment of this life-threatening cancer. This latest FDA approval means patients can benefit from Gleevec earlier in the course of their disease.”

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Monsanto seeks FDA approval for drought-tolerant corn

admin — Mon, 15 Dec 2008 11:11:08 +0000

KANSAS CITY, Missouri (Reuters) – Monsanto Co said Wednesday it filed for U.S. regulatory approval for what could be the world’s first drought-tolerant corn, a product that agricultural companies around the globe are racing to roll out amid fears of global warming and the needs of a growing population.
Monsanto said it submitted its product to the U.S. Food and Drug Administration for regulatory clearance. It is working with German-based BASF on the project.
The two companies are jointly contributing $1.5 billion to a venture aimed at developing higher-yielding crops and crops more tolerant to adverse environmental conditions, such as drought, which has eroded production in countries around the world in recent years.
“It’s been everybody’s dream to have a drought-tolerant crop,” said Iowa State University agronomist Roger Elmore, though he pointed out advantages would vary widely depending on geography.
Iowa, the largest U.S. corn-producing state, for instance, does not typically suffer severe drought. Last year, Iowa corn suffered from too much rain.
Monsanto said its first-generation drought-tolerant corn was in the final phase of development and should be launched early in the next decade.
The corn is designed to provide farmers yield stability during periods when water supply is scarce by mitigating the effects of drought — or water stress — within a corn plant.
U.S. field trials conducted last year met or exceeded the 6 percent to 10 percent targeted yield enhancement, equal to about 7 to 10 bushels per acre, over the average yield of 70 to 130 bushels per acre, Monsanto said.

Prism Pharmaceuticals wins FDA approval for cardiac arrhythmia drug

admin — Sat, 13 Dec 2008 20:51:50 +0000

Prism intends to submit a supplemental new drug application (NDA) for the premixed configurations which will form the focus of the commercial launch of Nexterone as a complete product line.
Prism is currently implementing a full scale manufacturing development program with the medication delivery business of Baxter Healthcare, a developer of premix technologies.
The FDA approval of Nexterone triggers a second $10 million milestone payment from Paul Capital. This long range financing agreement, established in September 2006, provides Prism with non-dilutive capital to enable the company to bring Nexterone through the period of NDA review and commercial launch.
Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
Warren Cooper, president and CEO of Prism, said: “We developed Nexterone to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias.”

Watson gets approval for mint-flavored Nicorette

admin — Thu, 11 Dec 2008 18:22:01 +0000

The Food and Drug Administration approved Watson Pharmaceuticals Inc.’s generic version of the nicotine gum Nicorette, the company said Wednesday, and Watson plans to start selling the mint-flavored gum in early January.
Watson said the FDA approved its over-the-counter nicotine polacrilex gum in 2 mg and 4 mg strengths. Nicorette is made by British drug maker GlaxoSmithKline PLC, and sold by Johnson & Johnson Healthcare. The FDA approved Nicorette in February 1996, and the gum is available in six flavors.
Perrigo Co. also makes a generic version of fruit-flavored Nicorette.
Watson said the total market for over-the-counter nicotine gum reached more than $300 million in the year ended September 2008.
Copyright 2008 Associated Press. All rights reserved. This material may not be published broadcast, rewritten, or redistributed

StemCells gets FDA approval for clinical trial

admin — Tue, 09 Dec 2008 18:27:21 +0000

has received approval from the Food and Drug Administration to begin a clinical trial of a product candidate to treat Pelizaeus-Merzbacher Disease (PMD), a fatal brain disorder that affects mainly young children.
Palo Alto-based StemCells (NASDAQ: STEM) designed the Phase 1 trial to evaluate the safety and efficacy of its HuCNS-SC product candidate cells as a treatment for PMD. Currently, there are no approved treatments for this disease, the company said.
This is StemCells second FDA approval for a clinical trial to evaluate the candidate cells as a potential treatment for neurodegenerative diseases. It has also received approval for a Phase I clinical trial to treat neuronal ceroid lipofuscinoses (NCL), or Batten disease. That trial is scheduled to be completed in January.
For the new trial the company has begun seeking approval by the Investigational Review Board of potential clinical trial sites, to begin enrolling patients.

UPDATE 2-FDA declines approval of Targanta's antibiotic

admin — Tue, 09 Dec 2008 17:19:58 +0000

(Adds analysts’ comments, updates stock movement)
Dec 9 (Reuters) – Targanta Therapeutics Corp said U.S. health regulators declined the approval of its antibiotic and raised questions about the safety of the drug, triggering a 63 percent drop in its shares.
The U.S. Food and Drug Administration asked the company to perform an additional clinical study to show efficacy and safety of the drug, oritavancin, for treating complicated skin and skin structure infections (cSSSI), Targanta said, citing a response letter from the FDA.
Analysts said the FDA response was expected, but were surprised by the safety issues raised by the agency as it was not mentioned previously.
The FDA mentioned several safety findings from the two pivotal studies for cSSSI, including a higher dropout rate and a greater number of patients who died or had a serious adverse event in the oritavancin-treated group, Targanta said.
Last month, an advisory committee to the FDA had narrowly voted against approval, saying it could not conclusively prove the drug was as effective as existing treatments, contradicting an earlier FDA staff determination.
Analysts expect the additional trial to take around two years to complete and believe that the company could secure a partner to meet its funding needs.
‘They need to somehow raise cash. Because they have a late-stage asset that has a relatively clear path to approval, albeit with some risk, they would probably get some commercial interest,’ Cowen and Co analyst Ian Sanderson said by phone.
He said a development or commercialization partnership was the most feasible alternative with the company.
However, the drug is expected to get approved eventually.
‘We believe that oritavancin, despite changing hands a couple of times, is a good drug with a number of differentiated characteristics,’ Leerink Swann analyst Howard Liang said.
Oritavancin was originally discovered and developed by
) Inc. Targanta acquired the worldwide rights to oritavancin from InterMune in late 2005.
Targanta is seeking FDA approval to sell the drug under the name Nuvocid for adults with complicated skin infections from a variety of bacteria, including some resistant to other antibiotics. Shares of Targanta were down 98 cents to $1.27 in midday trade. They had touched a low of 83 cents earlier in the day, making it one of the top percentage losers on Nasdaq.
(Reporting by Esha Dey in Bangalore; Editing by Himani Sarkar, Anil D’Silva) Keywords: TARGANTA/
(esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.reuters.com@reuters.net)
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