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.