The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Soliris (eculizumab; Alexion) for use in patients with neuromyelitis optica spectrum disorder (NMSOD), a complement-mediated disorder of the central nervous system.

The sBLA is supported by data from the phase 3 PREVENT study that evaluated the safety and efficacy of Soliris vs placebo in patients with anti-aquaporin-4 (AQP4) auto antibody-positive NMSOD. Results showed that Soliris reduced the risk of NMOSD relapse by 94.2% compared with placebo (P <.0001); 97.9% of Soliris-treated patients were relapse-free at 48 weeks compared with 63.2% of patients in the placebo arm. Moreover, compared with placebo, treatment with Soliris reduced the adjudicated on-trial annualized relapse rate by 95.5% (P <.0001).

Soliris, a complement inhibitor, is currently approved by the Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and for adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor (AchR) antibody positive.

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A Prescription Drug User Fee Act target date for the NMSOD indication has been set for June 28, 2019. “Given the debilitating impact NMOSD relapses can have on patients and the fact that there is currently no approved therapy, we are committed to getting SOLIRIS to these patients as quickly as possible,” said John Orloff, MD, Executive Vice President and Head of Research & Development at Alexion.

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