Posted by Michael Wonder on 12 Apr 2021
FibroGen receives fast track designation from the U.S. FDA for pamrevlumab for the treatment of Duchenne muscular dystrophy
12 April 2021 - FibroGen announced that the U.S. FDA has granted fast track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy.
This designation follows review of the Phase 2 clinical data from a single-arm trial in non-ambulatory patients with Duchenne muscular dystrophy, and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.
Pamrevlumab is currently being evaluated in two Phase 3 trials for the treatment of Duchenne muscular dystrophy.
