AstraZeneca’s Ultomiris approved in EU for adults firm NMOSD
Betsy Goodfellow | May 11, 2023 | News story | Medical Communications | AstraZeneca, NMOSD, Neurology, Ultomiris, neurology
AstraZeneca has announced the approval of Ultomiris (ravulizumab) in the European Union (EU) for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).
This approval makes Ultomiris the first and only long-acting C5 complement inhibitor for the treatment of AQP4 NMOSD to be approved in the EU. The approval by the European Commission (EC) follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as well as the positive results from the CHAMPION-NMOSD phase 3 trial, which were published in the Annals of Neurology.
Throughout the trial Ultomiris met its primary endpoint of time to first on-trial relapse as confirmed by an independent adjudication committee; no relapses were observed among the patients treated with Ultomiris during a period of 73 weeks.
Orhan Aktas MD, professor at the Department of Neurology, Medical Faculty at Heinrich-Heine-University, Düsseldorf, Germany, commented: “Effective NMOSD management hinges on reducing relapses – even a single relapse may cause irreversible disabilities leaving patients unable to move, speak or care for themselves. This approval in Europe will offer patients and physicians a new, long-acting treatment with unmatched relapse risk reduction, as Ultomiris showed zero relapses in its pivotal trial with dosing every eight weeks.”
Marc Dunoyer, CEO at Alexion, added: “Just four years since delivering the first approved NMOSD treatment to the EU, we are pleased to once again advance the treatment landscape with Ultomiris, which may eliminate relapses for people impacted by NMOSD. This approval is the culmination of extensive work and collaboration with the NMOSD community, including patients, caregivers and healthcare providers who participated in the CHAMPION-NMOSD trial, and we’re proud to continue improving access to our innovative medicines worldwide.”
Regulatory submissions for the drug are also under review with various health authorities, such as in the US and Japan.
Betsy Goodfellow
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