US FDA gives thumbs up for Boehringer Ingelheim's Pradaxa to prevent stroke in people with AF

Not surprisingly given an earlier advisory panel recommendation (The Pharma Letter September 21), the US Food and Drug Administration yesterday approved independent German drug major Boehringer Ingelheim’s Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

This means that Boehringer Ingelheim has won the race for US clearance of a replacement for warfarin, beating Pfizer/Bristol-Myers Squibb’s apixaban and Bayer/Johnson & Johnson Xarelto (rivaroxaban) into a global market that Bayer has said may reach $12 billion to $15 billion a year. Pradaxa is already sold in Europe to prevent clots after hip and knee surgery, as is Xarelto. Analysts at Decision Resources have predicted sales of $1.3 billion for Pradaxa by 2018 (TPL March 3).

Atrial fibrillation, which affects more than two million Americans, involves very fast and uncoordinated contractions of the heart’s two upper heart chambers (atria) and is one of the most common types of abnormal heart rhythm.