The U.S. Food and Drug Administration has approved satralizumab-mwge (Enspryng; Genentech) for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disorder of the central nervous system that damages the optic nerve and spinal cord, according to a press release.
It is the only approved treatment for NMOSD that inhibits interleukin-6 receptor activity, using novel recycling antibody technology.
Aatralizumab-mwge is administered by subcutaneous injection every 4 weeks and can be given at home by patient or caregiver.
Approval is based on results from the phase 3 SAkuraStar and SAkuraSky clinical trials, where the effects of satralizumab-mwge in adults with AQP4 antibody positive NMOSD were sustained for 96 weeks and significantly reduced the risk of relapse compared with placebo as a monotherapy and when used concurrently with baseline immunosuppressant therapy—a common way to manage NMOSD symptoms associated with relapses.
“Today’s FDA approval of Enspryng, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with Ocrevus to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “We thank the NMOSD community, including patients and investigators who participated in Enspryng clinical trials.”
View the full press release here.