Ultomiris approved in the USA for NMOSD

Ultomiris (ravulizumab-cwvz) has been approved in the USA as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).

Ultomiris was developed by US biotech Alexion and became part of AstraZeneca’s (LSE: AZN) portfolio following the UK pharma major’s $39 billion purchase of the rare disease specialist in 2021.

The supplemental Biologics License Application (sBLA) approval by the US Food and Drug Administration (FDA) was based on positive results from the CHAMPION-NMOSD Phase III trial. In the trial, Ultomiris, was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial.