Latest in Stroke-Prevention Saga: FDA Panel Backs Drug From J&J and Bayer

Xconomy New York — 

Yesterday I wrote about apixaban (Eliquis), a drug that Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) are developing to prevent strokes in patients with the heart-rhythm disorder atrial fibrillation. The folks at Bristol were paying close attention to a meeting at the FDA yesterday, during which an advisory panel to the agency voted on whether it should approve a stroke-prevention drug developed by Johnson & Johnson (NYSE: JNJ) and Bayer.

After the stock market closed, the panel handed down its verdict—and it was a good one for J&J and Bayer. The panel voted nine-to-two in favor of approval. (There was one abstention.) It was a surprisingly good outcome: Just two days earlier, the FDA posted a scathing review of the drug, rivaroxaban (Xarelto), on the Web. Shares of Bayer, which had dropped 7.5 percent on the Frankfurt exchange on Tuesday, recovered on Friday. J&J shares were unchanged in pre-market trading.

The FDA doesn’t have to follow the advice of its panels, but it usually does. J&J and Bayer expect to get a decision from the FDA on rivaroxaban in early November. Bristol and Pfizer, meanwhile, expect to file for approval of apixaban by the end of this year, which would mean a potential approval in the second half of next year. Both drugs are in a class known as “factor Xa inhibitors”—they block an enzyme that causes clotting.

What all these Big Pharma players are trying to do is develop alternatives to warfarin, a 60-year-old anti-clotting drug that’s effective and extremely affordable as a generic—but that also presents major challenges for patients. There are about 2.6 million Americans with atrial fibrillation, a condition that causes heart pounding and breathlessness, and that greatly increases … Next Page »

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