Lilly asks FDA to approve blood thinner

January 4, 2008

Indianapolis drug company Eli Lilly and Co. and its development partner met their year-end deadline to submit blood thinner prasugrel for regulatory approval. Lilly and Daiichi Sankyo Co. Ltd. filed for U.S. Food and Drug Administration approval on Dec. 26, they announced today.

Prasugrel could be a blockbuster if it successfully supplants the current best-selling blood thinner, Plavix, which racked up $6 billion in sales in 2006.

In a clinical trial, prasugrel reduced the risk of heart attack and stroke by 19 percent compared with Plavix, which is made by Bristol-Myers Squibb Co. and Sanofi-Aventis.

However, prasugrel also led to more serious bleeding in about 20 percent of patients. Some of the bleeding was fatal. Analysts reduced their sales projections for prasugrel and Lilly's stock price fell after the mixed clinical trial results were released in November.
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