FDA Approves J&J’s Xarelto For Treating Irregular Heart Beats-Atrial Fibrillation

Xarelto is normally prescribed as a blood thinner and now the FDA has given the stamp of approval to use for preventing strokes with patients that have irregular heart beats.  Warfarin has been the drug of choice for years that is hard to regulate and Xarelto also has a “black box” warning.  Bayer actually developed the drug along with J and J.  Speaking of Bayer it was on the net this week that Bayer DX was also laying off around 5% last week.  DX is a very different business model than straight pharma.  BD 

WASHINGTON — More than 2 million new U.S. patients will be eligible to receive a next-generation blood thinner drug called Xarelto, after the Food and Drug Administration approved the medication to treat a common heart problem that can lead to stroke.

Federal health officials approved the drug from Johnson & Johnson and Bayer to prevent strokes in patients with atrial fibrillation, a condition that causes the heart’s upper chambers beat chaotically and ineffectively. The irregular heartbeats can cause blood clots which travel to the brain, blocking blood flow and occasionally causing a stroke.

The FDA also added a restrictive "black box" to the drug's label, warning people against discontinuing use of Xarelto without consulting their doctors, as stopping abruptly may increase risk of stroke.

http://www.washingtonpost.com/business/fda-broadens-approval-of-jandjs-xarelto-for-patients-with-dangerous-irregular-heart-beats/2011/11/04/gIQArOtbmM_story.html

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