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

Health and Healthcare

Published: March 5, 2013 7:55 am

Last Updated: April 28, 2020 12:15 am

The 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.

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