Alexion’s Soliris almost entirely eliminates relapses in rare neuromyelitis optica spectrum disorder
pharmafile | September 26, 2018 | News story | Research and Development | Alexion, neuromyelitis optica spectrum disorder, pharma, rare disease, soliris
Alexion has revealed new Phase 3 findings for Soliris (eculizumab), showing the drug met its primary endpoint in the treatment of anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD), a rare central nervous system disorder characterised by relapses which can lead to paralysis, blindness and even premature death.
Patients with anti-AQP4 auto-antibodies represent around three-quarters of all NMOSD patients, and there are no currently approved therapies for the condition.
In the study, Soliris demonstrated a 94.2% reduction in risk of relapse compared to placebo; after 48 weeks of treatment, 97.9% of patients remained relapse-free, compared to 63.2% of those receiving placebo.
“The primary goal in treating NMOSD is relapse prevention as each relapse further increases disability, which makes this disease so devastating. For decades, we have been hoping for a therapy that can prevent relapse and subsequent accumulation of disability by addressing a critical underlying cause of the disease,” explained Dr Michael Levy, Associate Professor at Johns Hopkins University, and Director of the Neuromyelitis Optica Clinic in Maryland. “The substantial effect of Soliris seen in this groundbreaking randomized, controlled study in NMOSD could potentially become a turning point for patients and their families who live in constant fear of relapse.”
Dr John Orloff, Executive Vice President and Head of Research & Development at Alexion, added: “These results far exceeded our expectations. The remarkable reduction in relapse risk demonstrates the unique ability of Soliris to inhibit complement, and suggests a promising new treatment for NMOSD. Given that patients currently have no approved therapies, we are moving quickly to discuss these results with regulators and file for approval in the US, EU, and Japan.”
Matt Fellows
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