Lilly gets unanimous vote in favor of prasugrel

Shares of Eli Lilly sparked up ward Tuesday afternoon after the cardiovascular committee at the FDA unanimously recommended approval of its would-be blockbuster prasugrel. The committee said that the drug offered a clear improvement over the therapies already on the market.

For analysts, the vote marked a key watershed for the FDA. Many felt that a vote against prasugrel--or a vote in favor tied to a laundry list of safety warnings--would represent a clear signal that the agency would like to err on the side of caution. A vote in favor, they added, would indicate a willingness to accept a certain degree of risk for drugs that presented data on adverse events. In this case, Lilly had to deal with evidence that the drug prompted an increased risk of bleeding for some patients.

In the end, though, the panel seemed to side with the innovators. They recommended that the drug not be given to patients who have had a stroke. But rather than urge any additional limitations, the experts said that doctors should simply be sure to warn older patients and patients who weigh less than 130 pounds of the added risk of bleeding.

Consumer advocates, though, did raise concerns about the absence of the Safety and Risk Management Committee from the proceedings. Prasugrel is "too important a potential drug to make any big or even small mistakes," said Consumers Union's Steven Findlay.

- read the report in The Street
- check out the report in the Wall Street Journal 
- and read this story in the Wall Street Journal

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