AstraZeneca PLC on Wednesday said the European Commission approved its drug Ultomiris in the EU for adults with autoimmune disease neuromyelitis optica spectrum disorder, known as NMOSD.
The Cambridge, England-based pharmaceutical maker said the antibody complement inhibitor met the primary endpoint of time to first on-trial relapse, with a relapse risk reduction of just under 99% when compared to a placebo in a phase 3 trial.
Orhan Aktas, professor at the Department of Neurology, Medical Faculty at Heinrich-Heine-University, Dusseldorf, Germany, said: ‘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, chief executive officer at AstraZeneca’s rare-diseases focused subsidiary Alexion Pharmaceuticals, said: ‘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.’
AstraZeneca shares were down 0.7% to 11,826.00 pence each on Wednesday morning in London.
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