The USFDA has recently approved Satralizumab-mwge, as the third drug for treating neuromyelitis optica spectrum disorder (NMOSD) in adults with anti-aquaporin-4 antibodies (AQP4). The drug has received ‘fast track’ and ‘orphan drug’ designations for the above indication. NMOSD is a rare auto-immune disorder of the central nervous system that affects the optic nerves and spinal cord. Patients with NMOSD suffer from attacks of optic neuritis, which cause pain in the eyes and may lead to vision loss.
These attacks cause permanent visual impairments in 50% of the patients. The approval of the drug was based on two trials with a study duration of 96 weeks. Study 1 : A total of 64 out of 95 enrolled adult patients had antibodies against AQP4 and were treated with satralizumab. Treatment with satralizumab reduced the number of NMOSD relapses by 74% as compared to patients in the placebo group.…
