Bleeding Rates In TRA-2P Further Dim Outlook For Merck’s Vorapaxar
This article was originally published in The Pink Sheet Daily
Outcomes study of about 25,000 patients shows novel antiplatelet drug reduces events but also increases major bleeding, including intracranial hemorrhage.
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Merck does not yet know why DSMB decided no longer to study vorapaxar in stroke and ACS patients, but market analysts suspect a finding of excess bleeding.
FDA's approval of Lilly/Daiichi Sankyo's antiplatelet agent Effient (prasugrel) reflects the review team’s willingness to look past the increased risk of bleeding – a dramatic and viscerally alarming adverse event, though understandable due to the medical setting – to see the less immediately apparent benefit of a reduction in a type of cardiac event that includes so-called "silent MIs" that have no visible clinical presentation.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.