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Re: DewDiligence post# 172796

Friday, 05/09/2014 4:34:31 PM

Friday, May 09, 2014 4:34:31 PM

Post# of 257403
FDA approves MRK’s Zontivity (f/k/a vorapaxar), an antiplatelet drug, for secondary prevention of MI:

http://in.reuters.com/article/2014/05/08/us-merck-fda-idINKBN0DO1OF20140508

This approval has been a long time coming. Zontivity was once the leading drug candidate in Schering-Plough’s pipeline, but it sank into a deep pothole when the phase-3 data showed it increased major bleeding and mortality for patients with a prior stroke. Thus, patients with a prior stroke are explicitly excluded from the FDA label, which spceifies secondary prevention of MI for patents with a prior MI or existing PAD.

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