Company news: Boehringer Ingelheim

Share this article:
Boehringer Ingelheim won FDA approval for blood thinner Pradaxa (dabigatran) to prevent stroke in patients with atrial fibrillation (AFib). The twice-daily, oral med, which doesn't require anticoagulation monitoring like warfarin, could capture a sizable portion of the decades-old blood thinner's market. Boehringer Ingelheim, set to launch Pradaxa within days, is reaching the US market ahead of rivals Johnson & Johnson and Bayer, which filed an NDA for their own warfarin replacement, oral anticoagulant Xarelto (rivaroxiban), in 2008, and before Bristol-Myers Squibb and Pfizer, whose apixaban is in Phase III. J&J and Bayer received a complete response letter in 2009 requesting more clinical data on Xarelto, and FDA has yet to hand down a decision. The warfarin replacement market is so big, analysts estimate, that all three drugs should exceed $1 billion in US sales should they be approved. Pradaxa and Xarelto are already approved in other territories, including several countries of the EU.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.

Baxter seeks Cambridge, Mass. HQ

Illinois may be tempted to offer tax incentives for the firm to stay put.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.