FDA Approves Genentech’s Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)
August 14th, 2020
On August 14, 2020, the FDA approved Genentech’s EnspryngTM (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis.
News in brief
- Enspryng is the first and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks.
- Enspryng is also the first and only approved therapy for NMOSD designed to target and inhibit interleukin-6 (IL-6) receptor activity, using novel recycling antibody technology.
- The approval is supported by one of the largest clinical trial programs undertaken for this rare disease.
Supporting Information
“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. We thank the NMOSD community, including patients and investigators who participated in Enspryng clinical trials.”