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 20th, 2010

FDA Panel Unanimously Recommends Approval for Dabigatran

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of  dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw poll, a majority appeared to favor approval for both dosages. (The FDA reviewers had recommended approval for only the higher dosage.) Most panel members also supported language on the label summarizing the superiority of the 150 mg dose over warfarin in RE-LY.

Categories: Electrophysiology, Prevention
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4 Responses to “FDA Panel Unanimously Recommends Approval for Dabigatran”

  1. shabir ahmad, MBBS-MRCP says:
    September 20, 2010 at 7:29 pm

    I HOPE IN FUTURE WE MIGHT HAVE LONGACTING ACTING DABIGATRAN AS ONCE DAILY DASAGE.THIS IS A REMARKABLE ACHIEVEMENT IN THE FIELD OF CARDIOLOGY.

  2. VAZHA AGLADZE, MD., PhD says:
    September 21, 2010 at 1:24 am

    I THINK, THE ONLY PRIVILEGE OF WARFARIN REMAINS ONCE DAILY USAGE

    Competing interests pertaining specifically to this post, comment, or both:
    NO CONFLICTS OF INTEREST

  3. Pierre Scalise, MD says:
    September 21, 2010 at 10:43 am

    At least in the US, warfarin will remain much less expensive for the life of dabigatran’s patent protection unless insurers get smart and figure the cost of INR monitoring in with the cost of the drug.

    Competing interests pertaining specifically to this post, comment, or both:
    none

  4. Marilyn Kaswin, B.A., M.S., B.PH., Pharm.D says:
    September 22, 2010 at 6:27 pm

    The benefit of this drug even with its twice daily dosing regimen far outweighs the monitoring and food-drug and drug-drug interactions with warfarin. Other agents on the horizon including apixaban, rivaroxaban, betrixaban, and edoxaban may provide competition in terms of cost assuming that they will be approved for SPAF. Insurers will eventually jump on the bandwagon when these agents show lower hospitalization rates due to adverse events (i.e. bleeding) than warfarin.