approval

The U.S. Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvz) to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are positive for antibodies against the aquaporin-4 (AQP4) protein. About 75% of people with NMOSD produce antibodies that bind to AQP4, according to the therapy’s developer, Alexion…

Health Canada has approved Uplizna (inebilizumab-cdon) to treat adults in the country with neuromyelitis optica spectrum disorder (NMOSD) who test positive for disease-driving anti-aquaporin-4 (AQP4) antibodies. The decision adds Canada to the list of nations where the medication is now available. The intravenous or into-the-vein infusion, developed by…

Ultomiris (ravulizumab) is now approved in Canada to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are positive for antibodies against aquaporin-4 (AQP4). According to a press release from Alexion Canada, which will market Ultomiris in the country, it’s the “first and only” long-acting therapy…

Soliris (eculizumab) has been approved in China to treat adults with neuromyelitis optica spectrum disorder, known as NMO or NMOSD, who test positive for antibodies against the aquaporin-4 (AQP4) protein. The therapy — which works to reduce the risk of relapse and ease inflammation among patients — was approved…

Ultomiris (ravulizumab) has been approved by authorities in Japan to prevent relapses in adults with neuromyelitis optica spectrum disorder (NMOSD) positive for antibodies against aquaporin-4 (AQP4). The decision from the Japanese Ministry of Health, Labour and Welfare comes shortly after a similar approval by the European Commission,…

The Brazilian Health Regulatory Agency has approved Uplizna (inebilizumab-cdon) for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for antibodies against aquaporin-4 (AQP4-IgG). The Horizon Therapeutics’ therapy is the first and only man-made antibody against CD19 — a cell surface protein present…

The European Commission has approved Uplizna (inebilizumab-cdon) to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for antibodies against aquaporin-4 (AQP4-IgG). The approval covers all member states in the European Union, as well as Iceland, Liechtenstein, and Norway. Horizon Therapeutics, the company marketing Uplizna,…

The European Commission has approved Enspryng (satralizumab) for the treatment of people, 12 and older, with neuromyelitis optica spectrum disorder (NMOSD) who are positive for antibodies against the aquaporin-4 protein (AQP4-IgG). The approval covers Enspryng for use as a monotherapy (on its own) or in combination with other…