The US Food and Drug Administration issued more complete response letters than approval letters for novel agents over the past fortnight. The three CRLs included CBER’s high-profile rejection of the first gene therapy for hemophilia, while the agency cleared Genentech, Inc.’s Enspryng (satralizumab-mwge) and Cassiopea S.p.A.’s Winlevi (clascoterone).
The FDA also approved a new claim and a new name for the established Novartis AG antibody ofatumumab, with Kesimpta for relapsing multiple sclerosis joining the already-approved Arzerra for leukemia