U.S. panel backs Boehringer drug to reduce strokes
Tuesday, September 21, 2010
By: Lisa Richwine

Rueters

SILVER SPRING, Maryland (Reuters) - A new blood-thinning drug moved closer to U.S. approval on Monday, leading a pack of stroke-fighting medicines vying to compete in an estimated $10 billion a year market.

A U.S. advisory panel voted 9-0 to recommend clearance of Pradaxa, made by unlisted German drugmaker Boehringer Ingelheim, for preventing strokes in patients with a type of irregular heart beat.

The endorsement puts Pradaxa ahead of a possible competitors from partners Bayer and Johnson & Johnson, and Bristol-Myers Squibb Co and Pfizer.

The companies are racing to launch new oral anti-coagulant drugs to replace warfarin, a problematic 65-year-old medicine originally developed as rat poison.

Warfarin is the treatment of choice for people at high risk of stroke due to atrial fibrillation, a common form of irregular heart beat. But the drug interacts badly with food and other medicines, carries a high risk of bleeding and requires regular blood tests.

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