Update on forthcoming CHMP decision for betrixaban as a treatment for venous thromboembolism.- Portola Pharma

Portola Pharmaceuticals Inc.'s Factor Xa inhibitor betrixaban's future in the EU is looking uncertain after the EMA's CHMP issued a negative trend vote on the product's marketing application at its meeting this week. Betrixaban's negative trend vote means it is unlikely the committee will adopt a positive opinion on the company's MAA at the formal CHMP decision vote scheduled for March. The committee said that additional steps would be needed to gain marketing approval in Europe.

This European approach was in contrast to the broad label that the product received from the FDA in June as Bevyxxa for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism in patients hospitalized for an acute medical illness and at risk for thromboembolic complications, a large population; this followed a priority review by FDA with no advisory committee panel.