AstraZeneca Announces EU Approval of Ultomiris as the First Long-Acting C5 Inhibitor for AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder
AstraZeneca
Biopharmaceutical Manufacturer
European Union
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On May 10, AstraZeneca announced that the new indication for Ultomiris (ravulizumab), a long-acting C5 complement inhibitor, had been approved in the EU for the treatment of aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Ultomiris has also become the world's first long-acting C5 complement inhibitor approved for the treatment of NMOSD.
This approval was based on the positive results of the Phase III CHAMPION-NMOSD study. CHAMPION-NMOSD is an open-label, global multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Ultomiris in adult patients with NMOSD. The study enrolled a total of 58 patients, and for ethical reasons, no placebo group was set up. Instead, the results were compared with the external placebo group from the pivotal PREVENT study of the C5 inhibitor Soliris (eculizumab).
CHAMPION-NMOSD Study Results Show,After a median treatment duration of 73 weeks, zero adjudicated relapses were observed in the Ultomiris group (relapse risk reduction: 98.6%, HR (95% CI) = 0.014 [0.000, 0.103], p<0.0001).Moreover, 100% of patients treated with Ultomiris were relapse-free at 48 weeks, compared to 63% in the external placebo group.。
Main Efficacy Data (Source: AstraZeneca Official Website)
At the same time, the CHAMPION-NMOSD study also met key secondary efficacy endpoints, including the annualized relapse rate during the trial period (the total number of relapses in the study divided by the total number of patient-years) and clinically significant changes from baseline in mobility (walking ability) as measured by the Hauser Ambulation Index (a scale assessing mobility).
In terms of safety, the safety data of Ultomiris was consistent with the results observed in previous clinical trials, and no new safety signals were observed.
The original research company of Ultomiris is Alexion. In December 2020, AstraZeneca acquired Alexion for a total amount of $39 billion, bringing Ultomiris and eculizumab into its portfolio.
According to the PharmaCube database, Ultomiris was first approved in the United States in December 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). It has now been approved for four indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis, and neuromyelitis optica spectrum disorder (NMOSD). Meanwhile, Ultomiris is also undergoing Phase III clinical trials for several indications, including amyotrophic lateral sclerosis and acute kidney injury.
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