Ultomiris (ravulizumab) has strengthened its position in the market for neuromyelitis optica after obtaining approval for expanded indication.

On July 11th, the Ministry of Food and Drug Safety (MFDS) granted approval of expanded indication for Ultomiris, a C5 complement inhibitor, for the treatment of adults aged 18 years and above with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP-4) antibody-positive.

The approval of NMOSD indication was based on data from the external placebo-controlled, multi-center, open-label phase 3 CHAMPION-NMOSD trial, which evaluated the treatment effect and safety of Ultomiris.

The placebo used in the control grou