Expert panel set to review Boehringer's Pradaxa

On September 20, an FDA expert panel will review Boehringer Ingelheim's Pradaxa (dabigatran), an experimental blood thinner that the company says is safer, more effective and simpler to use than the generic warfarin. The drug is indicated to prevent stroke in those with irregular heartbeats.

It's good news for Boehringer, as some analysts speculated an expert panel wouldn't be scheduled to review Pradaxa until 2011. Bristol-Myers Squibb and partner Pfizer, Merck and Daiichi Sankyo are all racing to develop a warfarin replacement. But the panel date puts Boehringer in line to be the first company to market with a new class of blood thinner. The drug is already approved in non-U.S. markets for clot prevention knee or hip replacement patients.

Warfarin has been approved since 1954. While it's commonly used to prevent clotting, it's prone to interacting with many other drugs and even some foods. There's an unmet need for new drugs that are as effective and safer than current treatment options. According to the Wall Street Journal, Barclays estimates the anti-clotting drug market could hit $12 billion by 2021.

- read the Reuters piece
- check out the article from the WSJ

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