FDA Panel votes yes to vorapaxar for use as a blood thinner
The FDA cardiology expert panel voted on the pill vorapaxar on Wednesday with 10-1 results in favor of approval. The experimental drug vorapaxar, by Merck, was suggested as being used to prevent blood clots in patients with a history of heart attacks.
The experimental vorapaxar was under scrutiny for potentially causing bleeding, however it was determined that the benefits outweighed the risks.
Vorapaxar is defined as, “a thrombin receptor (protease-activated receptor, PAR-1) antagonist based on the natural product himbacine. Discovered by Schering-Plough and currently being developed by Merck, it is an experimental pharmaceutical treatment for acute coronary syndrome chest pain caused by coronary artery disease.”
“I think this drug addresses a real unmet medical need and can make a real difference for patients,” said Philip Sager, MD, acting chairperson of the committee.
Mori Krantz, MD, of the University of Colorado Denver states, “I voted No, not because I didn’t think the primary efficacy was met, but I worried about the size of the benefit and, in particular, with endpoints that were harder, such as cardiovascular death, where we’d need to treat nearly a thousand patients to have one person benefit.”
The risk of bleeding comes from an increased chance of intracranial hemorrhage with vorapaxar in patients with a history of stroke.
The panel has agreed that data should be printed on the label, as well as additional warnings. The new pill vorapaxar will potentially be called Zontivity.
Vorapaxar Approved By FDA For Use As Blood Thinner.