(Photograph credit: Wikipedia)
The FDA’s Cardiovascular and Renal Medicines Advisory Committee voted ten-1 in favor of approval for vorapaxar, Merck’s Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché may have been invented for this drug, which was the topic of tremendous early hopes followed by main disappointments and, finally, a subsequent revival.
The committee voted in favor of the drug for use as an adjunctive therapy for the reduction of atherothrombotic events in individuals with a background of myocardial infarction (MI). Panel chairperson Philip Sager explained that “this drug addresses a true unmet medical require and can make a real variation for sufferers.”
The University of Colorado’s Mori Krantz provided the a single unfavorable vote, however in his comments he indicated that he was not completely opposed to approval. He characterized his vote as a “formal dissent” and explained that he desired to get on the record his concerns about the large amount of individuals who would need to be taken care of with vorapaxar to stop a single occasion and his dread that the bleeding problems observed in the study may be amplified in the real world.
Sanjay Kaul stated that Merck ”convincingly demonstrated that the advantage exceeded the risk in the chosen patient cohort. Like all advancement programs, it has it’s fair share of warts, but there is an unmet need in this population where we have no safe and effective therapies accessible. Hopefully, if accredited it will be utilized in situations that optimize its advantage-risk profile.”
The panel spent much of the day wrestling with the complicated questions raised by the drug’s troubled history, in which a single massive trial, TRACER, was stopped early due to large charges of significant bleeding and the other trial, the TRA2P trial, was redesigned in midstream. But eventually the panel believed that TRA2P had been able to show that vorapaxar was successful in a post-MI population in which sufferers with a historical past of stroke had been excluded.
FDA Advisory Panel Votes In Favor Of Approval For Merck"s Vorapaxar
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