A little under three years ago, this candidate, one of Schering-Plough ex-CEO Fred Hassan’s five stars, clanked — and clanked loudly — on a pivotal Phase II/IIb study. That forced Whitehouse Station to take a $1.7 billion write-off on the research, to that point, in early 2011.
Now, with reams of additional data in tow, Merck is finally submitting the candidate for standard FDA review, on a full New Drug Application (the slowest US path to approvability):
. . . .Merck. . . today announced that the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack (TIA). . . .
We shall see if the data is enough to win an FDA approval — and if so, for which cardio-related indications. Even so, the indication listed is a shadow of the promise once claimed — it is now only a secondary line drug — at best.