Merck advances cardio drug under FDA review

Merck has made progress in its work toward an approval of its anti-thrombotic med called vorapaxar. The FDA has accepted the U.S. drug giant's ($MRK) application for approval of the medicine, granting the company a standard review that typically takes 10 months.

The company is asking for approval of vorapaxar for secondary prevention of cardiovascular events in patients who have suffered from a heart attack but have no history of stroke. Merck has left stroke victims out of the intended treatment population after study reviewers assessed the bleeding risk of the clot-buster.

Acquired in Merck's 2009 megamerger with Schering-Plough, vorapaxar is one of the late-stage hopes in Merck's pipeline of cardio meds. Advancing such drugs has been difficult for the company. Its HDL drug Tredaptive failed in late-stage development for FDA approval, prompting the company to withdraw the med from the European market.

The massive trials for such cardio meds have also taken a fair amount of Merck's massive $8 billion annual budget for R&D, which Roger Perlmutter has taken over this year with the challenging charge of improving productivity in the industry giant's drug research.

Acceptance of the vorapaxar application comes amid a rocky month for Merck on the regulatory front. The FDA denied approval of Merck's experimental sleep drug suvorexant at doses that proved most effective in clinical trials. A couple weeks later the agency dealt the Whitehouse Station, NJ-based company another setback, canceling an advisory committee meeting on sugammadex to give regulators more time to review data from a trial-site inspection.

- here's the release
- check out Reuters' coverage
- and the update from RTTNews

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