Merck Provides Update on Cardiovascular Development Programs
Merck (NYSE: MRK) provided an update Sunday on the development programs for vorapaxar, extended release niacin/laropirprant (MK524A, Tredaptive) and anacetrapib in association with the European Society of Cardiology meeting in Munich.
Vorapaxar: Merck now plans to file regulatory applications in 2013
Following a review of the clinical trial data and discussions with external experts, Merck now plans to file applications for vorapaxar, an investigational anti-thrombotic medicine in the United States 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.
Extended release niacin/laropiprant (MK-524A, Tredaptive): Merck confirms study on track to complete later this year
For MK-524A (Tredaptive), 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 United States and the European Union in 2013.
Anacetrapib: Merck provides information about a different method to measure LDL cholesterol and progress on REVEAL study Merck also today provided information about a different method to more accurately measure LDL-C when patients are treated with anacetrapib, an investigational CETP-inhibitor. Based on this method, called beta-quantification, anacetrapib 100 mg daily resulted in LDL-C reductions of approximately 25 to 35 percent, compared to the 40 percent reduction previously reported from the DEFINE (Determining the EFficacy and Tolerability of CETP INhibiition with AnacEtrapib) study and other anacetrapib studies.
"Merck remains committed to research to bring forward innovations in cardiovascular disease, which remains the leading cause of death worldwide," said Jeff Chodakewitz, M.D., senior vice president, Late Stage Development, Merck Research Laboratories. "The clinical outcomes studies for these three medicines have involved or will involve more than 90,000 patients around the world. All of these studies are designed to address the important question of whether, by adding these medicines to the current standard of care, we can further reduce the risk of cardiovascular events."
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