An international team of experts has published evidence-based recommendations for how to best treat people with neuromyelitis optica spectrum disorder (NMOSD) who are positive for aquaporin-4 immunoglobulin G (AQP4-IgG), the most common type of disease-driving antibody. The consensus statements were described in the study “International Delphi…
Drug approval
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,…
Ultomiris (ravulizumab) has been approved by the European Commission to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for antibodies against aquaporin-4 (AQP4). “Effective NMOSD management hinges on reducing relapses – even a single relapse may cause irreversible disabilities leaving patients unable to move, speak…
A European Medicines Agency (EMA) committee has recommended that Ultomiris (ravulizumab) be approved to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are positive for antibodies against aquaporin-4 (AQP4). The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), will now be reviewed by the European…
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…
SinoMab BioScience has been cleared by Chinese regulators to launch a clinical trial for its experimental immune-suppressing therapy SN1011 in people with neuromyelitis optica spectrum disorder (NMOSD). The company is anticipating that the Phase 2/3 trial will begin enrolling participants in early 2023. “The IND [investigational new drug]…
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,…
SB12, Samsung Bioepis’ biosimilar candidate of Soliris (eculizumab), is comparable to the original medication in terms of safety, pharmacological properties, and immunoreactivity profile, according to data from a Phase 1 clinical trial in healthy volunteers. Soliris, by Alexion Pharmaceuticals, is an approved therapy for a number of conditions,…
A committee of the European Medicines Agency has recommended approving Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for aquaporin-4 water channel autoantibodies (AQP4-IgG). This recommendation from the Committee for Medicinal Products for Human Use, known as CHMP, will now be reviewed by…
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…
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