Disappointing FDA briefing papers on Bayer/J&J's Xarelto

US Food and Drug Administration staffers posted a negative picture for German drug major Bayer (BAY: DE) and US partner Johnson & Johnson’s (NYSE: JNJ) ahead of the September 8 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss the New Drug Application for their Xarelto (rivaroxaban) tablets, for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with non-valvular atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).

The staff report released yesterday said that “there is insufficient information about the drug to determine whether it is safe for use with its proposed labeling.” The news saw Bayer’s shares plunge as much as 17% before closing the day down 7.5% at 37.75 euros in Frankfurt trading, while J&J fell 2% to $62.75 at 8.40 am in New York but ended the day 0.9% higher at $64.64.

Xarelto, a novel, once-daily, oral anticoagulant, is already approved in the USA and Europe for the prevention of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.