Alexion Says FDA Approves Soliris for Neuromyelitis Optica Spectrum Disorder

By Michael Dabaie

Alexion Pharmaceuticals Inc. (ALXN) said the U.S. Food and Drug Administration approved Soliris for the treatment of neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive.

About three quarters of all patients with NMOSD test positive for anti-AQP4 auto-antibodies, Alexion said.

The FDA approved Soliris following an expedited six-month priority review. NMOSD is a rare, severe autoimmune disease that attacks the central nervous system without warning. These attacks can cause progressive and irreversible damage to the brain, optic nerve and spinal cord, the company said.

In a Phase 3 trial, at 48 weeks 98% of patients treated with Soliris were relapse free compared to 63% of patients receiving placebo, Alexion said.

Shares of Alexion were up 0.95% to $126.53 in Thursday afternoon trading.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

June 27, 2019 14:49 ET (18:49 GMT)

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