
The FDA approved efanesoctocog alfa, a once-weekly treatment for children and adults with hemophilia A.
The approval applies to use of the factor VIII replacement therapy as routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment for control of bleeds, and for perioperative management of bleeding. Efanesoctocog alfa (Altuviiio; Bioverativ Therapeutics, Sanofi) is not indicated for treatment of von Willebrand disease.
“This is both a treatment and a prophylaxis, whereas other novel therapies are only prevention drugs,” Margaret V. Ragni, MD, MPH,