CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

September 16th, 2010

FDA: Dabigatran Gains, Lorcaserin Loses

An alternative to warfarin is one step closer to reality. On Thursday, The FDA released briefing documents for next Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at least as safe and effective as warfarin in the RE-LY trial. Cardiologists on the panel include the acting chair, A. Michael Lincoff, along with Steve Nissen, Sanjay Kaul, and Darren McGuire.

Also on Thursday, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended against approval of the diet drug lorcaserin (Lorqess, Arena). The vote was 9-5. Panel members felt the drug’s slim margin of efficacy in producing weight loss did not outweigh safety concerns that might arise in the real world.

Categories: General, Prevention
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One Response to “FDA: Dabigatran Gains, Lorcaserin Loses”

  1. Marilyn Kaswin, B.A., M.S., B.PH., Pharm.D says:
    September 17, 2010 at 4:14 pm

    I am not surprised about this one. RE-LY was groundbreaking. I just hope that nothing weird happens during post-marketing, like with ximelagatran.