AstraZeneca’s Ultomiris recommended for European approval in subset of NMOSD patients

03 Apr 2023
firstwordpharma.com
Phase 3Clinical ResultDrug ApprovalAcquisition
AstraZeneca said Monday that it has secured a positive opinion from the EU’s Committee for Medicinal Products for Human Use (CHMP) recommending the approval of Ultomiris (ravulizumab) for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+).
The recommendation is based on data from the Phase III CHAMPION-NMOSD study, which were presented in October at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference.
CHAMPION-NMOSD enrolled 58 adult participants and compared Ultomiris to the external placebo arm from the pivotal PREVENT trial of Soliris (eculizumab), another complement inhibitor marketed by AstraZeneca (following its acquisition of Alexion in 2020).
Findings showed that after a median 73 weeks of treatment, Ultomiris reduced the risk of relapse by 98.6%, compared to external placebo, with only two of the 58 patients experiencing clinically important worsening. Further, all patients receiving the drug remained relapse-free at 48 weeks, compared to 63% of patients in the external placebo arm.
Preventing relapses key, says expert
Orhan Aktas, Professor at the Department of Neurology, Medical Faculty at Heinrich-Heine-University, Düsseldorf, Germany, said: “Even one NMOSD relapse can lead to devastating long-term effects like vision loss, chronic pain and paralysis, which underscores the need for treatment innovations that help prevent relapses and optimise disease management.”
Assuming the European Medicines Agency (EMA) follows the CHMP’s guidance,  Ultomiris would be the first and only approved long-acting C5 complement inhibitorC5 complement inhibitor for the treatment of AQP4 Ab+ NMOSD in the EU.
Alexion CEO Marc Dunoyer noted “for patients with AQP4 Ab+ NMOSD, Ultomiris, the first and only long-acting C5 complement inhibitorC5 complement inhibitor, may have the potential to eliminate relapses, while also offering a convenient treatment schedule of infusions every eight weeks.”
Regulatory submissions for Ultomiris for the treatment of NMOSD are also currently under review with multiple health authorities, including in the US and Japan.
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