ULTOMIRIS® (ravulizumab-cwvz) Met Primary Endpoint in CHAMPION-NMOSD Phase III Trial in Adults with Neuromyelitis Optica Spectrum Disorder
- Category: Antibodies
- Published on Thursday, 05 May 2022 18:13
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Zero adjudicated relapses observed among ULTOMIRIS patients over a median treatment duration of 73 weeks
WILMINGTON, DE, USA I May 05, 2022 I Positive high-level results from the open-label Phase III CHAMPION-NMOSD trial showed that ULTOMIRIS® (ravulizumab-cwvz) achieved a statistically significant and clinically meaningful reduction in the risk of relapse in adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) compared to the external placebo arm from the pivotal SOLIRIS® PREVENT clinical trial.
ULTOMIRIS, the first and only long-acting C5 complement inhibitor, met the primary endpoint of time to first on-trial relapse, as confirmed by an independent adjudication committee. Notably, no relapse was observed in 58 patients over a median treatment duration of 73 weeks.
NMOSD is a rare and devastating autoimmune disease that affects the central nervous system (CNS), including the spine and optic nerves.1-3 Most people living with NMOSD often experience unpredictable relapses, a new onset of neurologic symptoms or worsening of existing neurologic symptoms, also referred to as attacks, which tend to be severe and recurrent and may result in permanent disability.4-6
Sean J. Pittock, MD, Director of Mayo Clinic's Center for Multiple Sclerosis and Autoimmune Neurology and of Mayo's Neuroimmunology Laboratory and lead primary investigator in the CHAMPION-NMOSD trial, said: “Every NMOSD relapse can have debilitating and irreversible consequences, so reducing relapses is critical. Patients on ULTOMIRIS remained relapse free over a median treatment duration of 73 weeks in the trial.”
Marc Dunoyer, Chief Executive Officer, Alexion, said: “SOLIRIS established the role of complement inhibition in preventing relapses in NMOSD, and with ULTOMIRIS, we continue to innovate for patients with a more convenient every eight-week dosing schedule. These trial results show that ULTOMIRIS may help patients move towards eliminating relapses, which is an important advancement in the treatment of NMOSD.”
The safety and tolerability of ULTOMIRIS in the Champion-NMOSD trial were consistent with previous clinical studies and other approved indications. Fifty-six patients are continuing to receive treatment in a long-term extension period, which is ongoing.
The data will be presented at a forthcoming medical meeting and submitted to global health authorities as rapidly as possible to bring forward ULTOMIRIS to the NMOSD community.
INDICATION(S) & IMPORTANT SAFETY INFORMATION for ULTOMIRIS® (ravulizumab-cwvz)
What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine used to treat:
- adults and children 1 month of age and older with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).
- adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
- adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.
Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. As a leader in rare diseases for nearly 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. For more information, please visit www.alexion.com.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
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- ClinicalTrials.gov. An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD. NCT Identifier: NCT04201262. Available online. Accessed April 2022.