Alexion’s Soliris scoops up expanded EU approval in neuromyelitis optica spectrum disorder
pharmafile | August 28, 2019 | News story | Research and Development, Sales and Marketing | Alexion, FDA, US, pharma, soliris
Alexion has announced the expanded EU approval of Soliris (eculizumab) as a treatment for neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
The indicated population accounts for around three-quarters of all cases of the rare autoimmune condition, with 73% of NMOSD patients testing positive for anti-AQP4 antibodies. The disease is characterised by attacks on the central nervous system which can cause irreparable damage to the brain, spinal cord and optic nerve, potentially causing long-term disability.
The approval was based on Phase 3 data showing that the therapy met its primary endpoint of prolonging the time to first adjudicated relapse and reducing the risk of relapse. After 48 weeks of treatment, 98% of Soliris patients were relapse-free, compared to just 63% with placebo; after 144 weeks, 96% of Soliris patients remained relapse-free, while on 48% of placebo patients achieved the same.
Additionally, 100% of patients who had only received Soliris and no other immunosuppressive therapies remained relapse-free after 144 weeks, compared to 20% with placebo.
“NMOSD is a serious disease with devastating consequences,” commented Dr Michael Levy, Associate Professor of Neurology at Massachusetts General Hospital and consultant to Alexion. “Each attack can result in potentially irreversible consequences – causing blindness or losing the ability to walk – so preventing relapse is the primary goal of treatment. With the approval of SOLIRIS, there is now for the first time an FDA-approved treatment available to NMOSD patients to help reduce the risk of relapse.”
Soliris secured approval from the FDA in the US back in June this year, and is currently under review in Japan.
Matt Fellows
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