South African experts comment on FDA approval of dabigatran in atrial fibrillation.

摘要

The US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 in favour of recommending dabigatran etexilate, an oral direct thrombin inhibitor for stroke prevention in patients with non-valvular atrial fibrillation (AF).The FDA approved the standard dose of 150 mg bid (as also submitted by Boehringer Ingelheim in the European Union) without dose adjustments for tested p-GP inhibitors or for moderately renal-impaired patients.No approval was given for the 110-mg strength; the justification seems to be that FDA felt the evidence was better for the 150-mg dose. However, the approval of the 75-mg strength for patients with severe renal impairment (15-30 ml/min) was driven by the FDA, based on criteria modelling.Boehringer Ingelheim (BI) SA commented that the omission of the 110-mg dose came as a surprise and BI strongly supports the market need for both doses to be made available so physicians will be able to tailor therapy.