Merck to accelerate Tredaptive NDA re-filing
Executive Summary
Merck plans to file an NDA for its cholesterol drug Tredaptive (niaicin/laropiprant, previously known as Cordaptive) in 2012, a year earlier than expected, firm announces during annual business briefing Dec. 9. In order to meet that goal, it is accelerating by a year-also to 2012-c ompletion of a major, ongoing Oxford University-led outcomes study, which aims to assess Tredaptive's impact versus placebo on risk of potential major vascular events in certain patient groups, The study, which originally intended to enroll 20,000 patients, will now evaluate 25,000 patients. Earlier this year, FDA issued a complete response letter for the NDA, demanding outcomes data. Merck had been hoping to launch the drug before patents on several key products expire, including Cozaar/Hyzaar (losartan/hydrochlorothiazide/losartan) in 2010 and Singulair (montelukast) in 2012
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