US FDA clears Bayer/Johnson & Johnson's Xarelto for stroke risk reduction in AF patients

In what was much-awaited good news for German drug major Bayer (BAY: DE), its US subsidiary announced late Friday (November 4) that the US Food and Drug Administration had finally approved its blood thinner Xarelto (rivaroxaban) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Bayer’s shares rose 3.9% to 46.65 euros in morning trading today, in a falling German market.

Xarelto is the only oral anticoagulant approved in the USA that offers once-daily dosing, without the need for routine blood monitoring, said US marketing partner Janssen Pharmaceutical, a Johnson & Johnson (NYSE: JNJ) company. However, Xarelto will have to compete in a market sector valued at around $9 billion (some estimates go as high as $20 billion for warfarin replacement products) with already approved Pradaxa (dabigatran) from German independent drug major Boehringer Ingelheim and yet to be cleared Eliquis apixaban) from Pfizer and Bristol-Myers Squibb.

The FDA approval of Xarelto, which on July 1 was cleared by the agency to reduce the risk of blood clots, deep vein thrombosis and pulmonary embolism following knee or hip replacement surgery for the new indication, was by no means a foregone conclusion as, despite an FDA advisory committee voting nine to two (with one abstention) recommending approval, agency staff briefing papers to investigators ahead of that meeting had been somewhat negative (The Pharma Letters September 7 and 9). Xarelto is currently under review by European and Japanese regulators for this use, and has been touted as having a peak sales potential of around 2 billion euros ($2.8 billion) outside the USA.