EU backs Bayer's Xarelto for stroke prevention

The European Commission has approved two new indications for German drug major Bayer HealthCare’s (BAY: DE) Xarelto (rivaroxaban), making it the only new oral anticoagulant approved in three indications across all 27 European Union member states for: • prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors;• treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults; and • the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery. The move follows a European Medicines Agency advisory panel recommendation in the fall (The Pharma Letter September 26).

Bayer has previously said it expects peak sales of more than 2 billion euros ($2. billion) for Xarelto (TPLs passim), which has also gained approval for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation in the USA, where it will be co-marketed with domestic pharma major Johnson & Johnson, but will only receive up to 30% of revenues generated in that market (TPL November 7). 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 the USA’s Pfizer and Bristol-Myers Squibb.

Once-daily treatment advantage