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  • Ultomiris gets expanded indication for neuromyelitis optica
  • by Hwang, Byung-woo | translator Kang, Shin-Kook | Jul 17, 2024 05:50am
strengthening its competitiveness in the market
Approved for the treatment of adult patients with anti-aquaporin-4 (AQP-4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD)
In the Phase 3 CHAMPION-NMOSD trial, it reduced the risk of recurrence by 98.6%
With an 8-week interval treatment, Ultomiris improves convenience compared to Soliris
Ultomiris (ravulizumab) has strengthened its position in the market for neuromyelitis optica after obtaining approval for expanded indication.

 ¡ã Product photo of Ultomiris
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 group was the placebo from Soliris¡¯ pha
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