Ultomiris

None of the neuromyelitis optica spectrum disorder (NMOSD) patients in the Phase 3 CHAMPION-NMOSD clinical trial have had a disease relapse while on Ultomiris (ravulizumab-cwvz) treatment for a median of more than 2.5 years. These findings were shared by Sean Pittock, MD, the trial’s principal investigator, at the…

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…

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…

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…

Ultomiris (ravulizumab) — Alexion Pharmaceuticals’ approved therapy for certain complement-associated disorders — prevents relapses in adults with neuromyelitis optica spectrum disorder (NMOSD) who are positive for antibodies against the aquaporin-4 (AQP4) protein. The therapy also helped preserve walking skills, with treated patients showing a markedly lower risk of experiencing clinically…