FDA Approves Treatment for Neuromyelitis Optica Spectrum Disorder

 

The US Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) to treat neuromyelitis optica spectrum disorder (NMOSD) among adults with the anti-aquaporin-4 (AQP4) antibody.

“Until last year, there were no FDA-approved treatments for patients with this rare, debilitating and sometimes fatal disease. Now there are [3],” said Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a press release. “Today’s approval of Enspryng highlights the FDA’s commitment to rapidly advancing safe and effective therapies for NMOSD and other neurological diseases.”

The most common adverse effects associated with Enspryng are nasopharyngitis, upper respiratory tract infection, headache, rash, inflammation of stomach lining, extremity pain, joint pain, nausea, and fatigue.

Enspryng is associated with an increased risk of infection, including the possible reactivation of tuberculosis and hepatitis B virus. Other warnings in the prescribing information for Enspryng include the potential for elevated liver enzymes, hypersensitivity reactions, and decreased neutrophil counts.

—Christina Vogt

Reference:
FDA approves treatment for rare disease affecting optic nerves, spinal cord. News release. US Food and Drug Administration. August 17, 2020. Accessed August 17, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-rare-disease-affecting-optic-nerves-spinal-cord