The European Commission has given its approval to Bayer's Jivi treatment for patients with haemophilia A. Bayer has now received approval from the US Food and Drug Administration and regulators in Japan. In a statement, Bayer said it was "pleased that the FDA has approved our drug for use in people who have been treated by other therapies. The EU's approval was based on a study which showed 100% success in patients treated every five days and a 74% success rate in those dosed weekly, in terms of bleed protection.
The European Commission has given its approval to Bayer's Jivi treatment for patients with haemophilia A. Bayer has now received approval from the US Food and Drug Administration and regulators in Japan. Jivi is the third treatment in Bayer's haemophilia portfolio. The EU's approval was based on a study which showed 100% success in patients treated every five days and a 74% success rate in those dosed weekly, in terms of bleed protection.