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WASHINGTON — The Food and Drug Administration has approved a highly anticipated blood thinner from Eli Lilly after more than 18 months of review.
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The approval makes Lilly's Effient the first real competition to the blood thinner Plavix, the world's second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibb.
The FDA delayed its decision on Effient multiple times as reviewers weighed the drug's benefits versus its risks
A study of over 13,000 patients conducted by Lilly found that Effient prevents more heart attacks than Plavix, but also causes more internal bleeding.
The FDA says Effient will carry a boxed warning to alert physicians to the risks of potentially fatal bleeding.
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