Merck ($MRK) has revealed updates for key meds in the U.S. drug giant's pipeline of cardiovascular drugs. And the plans call for the company to ask regulators for approvals of two cardio drugs--vorapaxar and Tredaptive--next year as the Whitehouse Station, NJ-based pharma works to beef up its lineup of commercial products.
Salvaging a tarnished gem from its Schering-Plough merger, Merck aims to seek U.S. and European approvals of the clot-buster vorapaxar next year. Last year bleeding concerns befell the experimental med and safety reviewers reasoned that stroke victims shouldn't take the drug, Reuters reported. Merck now plans to seek approvals for use of the drug to prevent cardio events, but not for patients who have suffered a stroke.
Meantime, Merck assured investors that the late-stage HPS2-THRIVE study for cholesterol drug Tredaptive would wrap up later this year, with the company readying to apply for green lights to sell the drug in the U.S. and Europe next year. Physicians have already enrolled 20,000 patients in the REVEAL study for a third cardio drug, anacetrapib, putting them on track to finish the massive trial in 2017. Both Tredaptive and anacetrapib have been highlighted in Merck's pipeline on which the giant invests more than $8 billion annually.
Anacetrapib has impressed with earlier data on the reduction in cholesterol in patients on the experimental med. Yet in Merck's update, the company may temper that enthusiasm with its new method of calculating the reductions in LDL cholesterol from the DEFINE study. The new method shows that a 100 mg daily dose of the drug provided a 25% to 35% fall in LDL-C, as opposed to the 40% previously calculated.
- here's the release
- see Reuters' article
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