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As FDA Delays Ruling on Eli Lilly Drug, Clock Ticks on Plavix Patent

blogs.wsj.com

The FDA was supposed to decide this week whether to approve Eli Lilly’s blood thinner prasugrel, but the agency said yesterday that the decision would take another three months. It’s a complicated decision — in a big study, prasugrel was more effective than Plavix at preventing blood clots, but it also carried a greater risk of causing internal bleeding.

Blood thinners are tricky that way. Greater effectiveness is often tied to greater risk of side effects. Plavix, co-marketed by Bristol-Myers Squibb and Sanofi-Aventis, has grown to be an $8 billion a year drug as doctors have grown comfortable with the risks and benefits.

If prasugrel (brand name: Effient) wins approval, sales will be affected by doctors’ comfort level with the drug, as compared to Plavix. Getting docs to switch from Plavix to prasugrel (at least for some patients) could grow even tougher in 2011, when cheap, generic versions of Plavix are expected to become available in the U.S.

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