Pradaxa regulatory update

FDA reiterated its recommendation that Boehringer's Pradaxa dabigatran etexilate provides an important additional benefit when used as directed following its review of new information regarding the risk of serious bleeding in patients receiving the atrial fibrillation (AF) drug. The decision follows an investigation of insurance claims and administrative data from FDA's Mini-Sentinel pilot of the Sentinel Initiative that showed rates of gastrointestinal bleeding and intracranial hemorrhage associated with new users of Pradaxa "did not appear to be higher" than rates associated with new users of the anticoagulant warfarin. Boehringer also said EMA's CHMP issued a positive opinion last month to renew marketing authorization of Pradaxa. The product is approved in the U.S. and EU to prevent stroke and blood clots in patients with AF and in the EU to prevent venous thromboembolic (VTE) events in adults who have undergone elective total hip or knee replacement surgery and to prevent systemic embolism in patients with non-valvular AF. ...