The Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge; Genentech Inc.) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults.
Enspryng is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. FDA approval of Enspryng is supported by clinical trial results. The FDA granted this application fast track designation. The drug also received orphan drug designation, which provides incentives to assist and encourage drug development for rare diseases.
A Hayes Emerging Technology Report on Enspryng is available here.
Food and Drug Administration (FDA). FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord [news release]. August 17, 2020. Available at: click here. Accessed August 18, 2020.