Friday, February 20, 2015

Vorapaxar (Branded As Zontivity®) May Ultimately Turn Out To Be Not So Terribly Waifish, Afterall

Approved in May 2014, after manifold, multi-year delays, Zontivity® (vorapaxar) has had a bit of a bumpy ride. More background here.

But a forthcoming study in the journal Circulation may slightly improve sales for the beleaguered legacy Schering-Plough drug. [This was one of Fast Fred's 2008-2009 "five stars". . . that became a "has been," before it "ever was". Almost a "never was," in fact.] It seems the PAR-1 inhibitor is showing some moderate efficacy in diabetic patients with a prior history of MI (without -- thus far -- undue breakthrough bleeds). And that is not a small population, either. Here's the snippet:

. . . .Patients with diabetes who have had an MI are at particularly increased risk for recurrent ischemic events, but a new study published online February 13, 2015, ahead of print in Circulation suggests that the addition of the novel antiplatelet agent vorapaxar provides effective long-term secondary prevention of cardiovascular events and stroke in this subgroup.

“Our data raise the possibility that vorapaxar [Zontivity; Merck Sharp & Dohme], which inhibits platelets via a pathway separate from that of aspirin and P2Y12 inhibitors. . . offers a particular advantage for patients with [diabetes],” write David A. Morrow, MD, MPH, of Brigham and Women’s Hospital (Boston, MA), and colleagues. Vorapaxar inhibits PAR-1, the predominant receptor for thrombin on the surface of platelets. Take Home: Vorapaxar Effective for Secondary Prevention in Diabetic Patients With Prior MI

The TRA 2°P-TIMI 50 study included 26,449 patients with stable atherosclerosis who were randomized to receive standard care, including aspirin, and either vorapaxar (2.5 mg daily) or placebo at 1,032 sites in 32 different countries. It demonstrated a reduction in the composite of cardiovascular death, MI, or stroke at 3 years with vorapaxar vs placebo. . . .

Well. . . it will still never be a blockbuster, in my opinion -- but it may break the $200 million a year mark -- for peak sales, at some point, now. Just my newly revised guess, here.

1 comment:

Anonymous said...

The data on efficacy of vorapaxar in this sub-population is actually quite compelling. The additional bleeding seen in the 2 big studies likely was a consequence of adding vorapaxar on top of clopidogrel/ASA.