FDA Grants Sanofi’s Rare Hemophilia Drug Fast-Track Status
The FDA has granted Sanofi’s efanesoctocog alfa Fast-Track designation for treating patients with hemophilia A, a rare form of the bleeding disease that mainly affects males.
The prophylactic is currently being evaluated in an ongoing phase 3 study enrolling patients 12 years old and younger with severe hemophilia A, for up to 52 weeks. The trial will conclude in January 2022, according to ClinicalTrials.gov.
Efanesoctocog alfa previously received Orphan Drug designation from the FDA in August 2017 and from European regulators in June 2019.