FDA, Regulations

Sanofi and Sobi’s Altuviiio label updated by FDA with expanded paediatric data in haemophilia A

May 20, 2024


Haemophilia A is a rare hereditary bleeding disorder that occurs when there is a lack of sufficient functioning factor VIII protein to help the blood clot, leading to external bleeding, bruising and bleeding into joints. Designed to extend protection from […]

FDA, Regulations

FDA Approves Sanofi’s Once-weekly ALTUVIIIO for Hemophilia A

February 24, 2023

Via: Contract Pharma

The U.S. FDA has approved Sanofi’s ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy. ALTUVIIIO is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as […]