Eli Lilly, Daiichi Sankyo's Effient garners FDA approval

The FDA announced that it approved Eli Lilly and Daiichi Sankyo's antiplatelet agent Effient (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty. The agency also noted that the product's label will include a boxed warning to advise of the potential for "significant, sometimes fatal, bleeding." The companies indicated that they expect to launch Effient in the US in the coming weeks.

Data from a trial involving over 13 600 patients compared Effient to sanofi-aventis' and Bristol-Myers Squibb's Plavix (clopidogrel) in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty, the US regulator stated. Results showed that the fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in the Plavix arm to 7 percent in those who took Effient. A greater risk of significant bleeding was observed in patients taking Eli Lilly's and Daiichi Sankyo's drug.

The boxed warning will advise that Effient should not be used in patients "with active pathological bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery." Spokeswoman Laura Hortas of Bristol-Myers Squibb indicated that Effient is approved only for a portion of the patient population for which Plavix is approved.

Commenting on the warning label for Effient, analyst Les Funtleyder of Miller Tabak & Co. noted that "the FDA has been a lot more liberal with black-box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare...But it still has the ability to somewhat limit sales." Deutsche Bank analyst Barbara Ryan added: "I think it will make it tough for [Effient] to compete against Plavix." She remarked that her previous projection for peak annual sales of $1 billion for Effient might be too high. Meanwhile, Caris & Company analyst David Moskowitz speculated that Eli Lilly's and Daiichi Sankyo's product will have revenue of $500 million by 2013 and will probably hold up to 25 percent of the market at its peak. He explained that "it's going to take time for them to penetrate the market with this label."

In response to the concerns, Anthony Ware, a vice president in Eli Lilly's research business, said he didn't think the boxed warning would be a significant detriment to the marketing of Effient. "We think it's important to let patients and the physician know about the bleeding risks, which can sometimes be serious...and to be able to balance that with efficacy," he stated.

The antiplatelet agent was launched in April in Europe, where it is sold as Efient.

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