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AstraZeneca’s Ultomiris recommended for approval in the EU

Marc Dunoyer

Ultomiris has been recommended for marketing authorization in the European Union for the treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive.

If authorised, Ultomiris would be the first and only approved long-acting C5 complement inhibitor for the treatment of AQP4 Ab+ NMOSD in the EU, states the company.

“For patients with AQP4 Ab+ NMOSD, Ultomiris, the first and only long-acting C5 complement inhibitor, may have the potential to eliminate relapses, while also offering a convenient treatment schedule of infusions every eight weeks. We look forward to the European Commission decision as we work to make Ultomiris available to people living with NMOSD in the EU and around the world,” says Marc Dunoyer, Chief Executive Officer, Alexion.

Based on results from the CHAMPION-NMOSD trial

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the CHAMPION-NMOSD Phase III trial. In the CHAMPION-NMOSD trial, Ultomiris was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial.

Ultomiris met the primary endpoint of time to first on-trial relapse as confirmed by an independent adjudication committee. Notably, data showed zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks, and continuing through a median duration of 90 weeks. Overall, the safety and tolerability of Ultomiris were consistent with previous clinical studies and real-world use. No new safety signals were observed. The most common adverse events (AEs) were COVID-19, headache, back pain, arthralgia and urinary tract infection. All cases of COVID-19 were non-serious and considered to be unrelated to Ultomiris, states the company.

Regulatory submissions for Ultomirisfor the treatment of NMOSD are also currently under review with multiple health authorities, including in the United States (US) and Japan.

Photo of Marc Dunoyer: Alexion