US FDA advisory panel backs approval of Bayer/J&J's Xarelto for stroke prevention

There must have been a palpable sigh of relief last night across Leverkusen, the headquarters of Germany’s Bayer AG (BAY: DE), when the US Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee recommended approval of the company’s Xarelto (rivaroxaban) for the expanded indication of the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) in the USA.

Despite what appeared to be relatively negative briefing papers from FDA staffers earlier this week (The Pharma Letter September 7), the committee voted nine to two (with one abstention) in favor of approving rivaroxaban in this indication. A decision by the FDA, which is not bound to take the advise of the panel but usually does, is expected in early November 2011. Xarelto is licensed to Janssen Pharmaceuticals, a Johnson & Johnson (NYSE: JNJ) company for the US market. The New Drug Application was filed by Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) in January this year.

Would enter a potential $14 billion market sector