September 20th, 2010
FDA Panel Unanimously Recommends Approval for Dabigatran
Larry Husten, PHD
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.
4 Responses to “FDA Panel Unanimously Recommends Approval for Dabigatran”
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I HOPE IN FUTURE WE MIGHT HAVE LONGACTING ACTING DABIGATRAN AS ONCE DAILY DASAGE.THIS IS A REMARKABLE ACHIEVEMENT IN THE FIELD OF CARDIOLOGY.
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
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
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.