Panel endorses Merck's anti-clotting drug
Advising the FDA to “do its due diligence” about bleeding risk, an FDA panel voted 10-1 in favor of Merck's anti-clotting drug vorapaxar, which would have the brand name Zontivity, Reuters reports. The panel and Merck want to limit the drug's use to heart attack patients without a stroke history, because of an increased bleeding risk among stroke patients.
Aspirin, and Bristol-Myers Squibb's now off-patent Plavix (clopidogrel) seek the same goal—to prevent clots—but Reuters notes Merck's potential market peer works differently, by inhibiting a PAR-1 receptor.
The panel also says the drug should come with a weight minimum because lighter patients appear to be at a higher risk for bleeds.