J&J, Bayer Fail to Gain FDA Approval for Blood Thinner

PillsThe U.S. Food and Drug Administration (FDA) last night rejected an application from Johnson & Johnson (NYSE: JNJ) and Germany's Bayer A.G. to extend the use of the two companies' blood thinning drug Xarelto for reducing risk of heart attacks and strokes in patients with chest pain or previous cardiac illness. The drug was approved in 2011 for use to prevent clotting during some joint replacement surgeries, and its use has been expanded to treat irregular heartbeats and other types of blood clots.

J&J owns the rights to the drug and Bayer has licensed the rights to market the drug in Europe. Xarelto (rivaroxaban) is one of several drugs being promoted as replacements for warfarin, the standard blood-thinning agent for the past 50 years or so. AstraZeneca PLC (NYSE: AZN) and Eli Lilly & Co. (NYSE: LLY) already have drugs approved to treat what is called acute coronary syndrome.

There should be little impact on share price today, because an FDA panel already had rejected the drug for this expanded use in June of last year. J&J shares set a new 52-week high yesterday and closed up about 0.7%, at $77.20 in a new 52-week range of $61.71 to $77.28.


Filed under: 24/7 Wall St. Wire, Drug companies, Pharmaceuticals, Regulation Tagged: AZN, JNJ, LLY
Read Full Story

Markets

NASDAQ 6,426.92 4.23 0.07%
S&P 500 2,502.22 1.62 0.06%
DJIA 22,349.59 -9.64 -0.04%
NIKKEI 225 20,416.78 120.33 0.59%
HANG SENG 27,880.53 -229.80 -0.82%
DAX 12,592.35 -7.68 -0.06%
USD (per EUR) 1.19 0.00 0.03%
USD (per CHF) 0.97 0.00 0.02%
JPY (per USD) 112.47 0.02 0.02%
GBP (per USD) 1.35 0.00 0.12%

Can't get enough business news?

Sign up for Finance Report by AOL and get everything from retailer news to the latest IPOs delivered directly to your inbox daily!

Subscribe to our other newsletters

Emails may offer personalized content or ads. Learn more. You may unsubscribe any time.