Merck & Co to file for approval of two heart drugs next year

28 August 2012

US drugs giant Merck & Co (NYSE: MRK) says that, following a review of the clinical trial data and discussions with external experts, it now plans to file marketing applications for its investigational anti-thrombotic drug vorapaxar in the USA and the European Union in 2013.

Merck plans to seek an indication for the prevention of cardiovascular events in patients with a history of heart attack and no history of TIA (transient ischemic attack) or stroke. Discussions with worldwide regulatory agencies are continuing and we will update this information when appropriate.

For MK-524A (extended release niacin/laropirprant, Tredaptive, which is already marketed), Merck also confirmed that the HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) study is on track to complete later this year, and Merck plans to file in the USA and the EU in 2013.

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