Posted by Michael Wonder on 15 Aug 2020
FDA approves Genentech’s Enspryng for neuromyelitis optica spectrum disorder
14 August 2020 - First and only FDA approved subcutaneous treatment option for anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder that can be self-administered by a person with neuromyelitis optica spectrum disorder or a caregiver every four weeks.
Genentech today announced that the U.S. FDA has approved Enspryng (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder.
This approval is supported by results from two randomised controlled Phase III clinical trials, the SAkuraStar and SAkuraSky studies, in which Enspryng demonstrated robust and sustained efficacy and a favourable safety profile in adults with AQP4 antibody positive neuromyelitis optica spectrum disorder .
