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# Alexion Files sBLA for Soliris Expanded Use
- URL: https://www.fdaweb.com/alexion-files-sbla-for-soliris-expanded-use/
- Published: 2019-02-22T12:00:00.000Z
- Updated: 2026-09-15T01:07:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143446

FDA has accepted for review an Alexion Pharmaceuticals supplemental BLA for the use of Soliris (eculizumab) in treating patients with neuromyelitis optica spectrum disorder (NMOSD) who have anti-aquaporin-4 (AQP4) auto antibodies. The submission is supported by data from the [PREVENT study in patients with anti-AQP4 auto antibody-positive NMOSD](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fnews.alexion.com%2Fpress-release%2Fproduct-news%2Falexion-announces-successful-phase-3-prevent-study-soliris-eculizumab-pat&esheet=51944971&newsitemid=20190222005474&lan=en-US&anchor=successful+PREVENT+study+in+patients+with+anti-AQP4+auto+antibody-positive+NMOSD&index=2&md5=742ab2f0970f4c48daafbb35df89a0b1&ref=fdaweb.com). The agency has granted priority review and set a 6/28 user fee review action target date. The therapy is currently approved for treating patients with paroxysmal nocturnal hemoglobinuria.

NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterized by relapses, the company says. “Each relapse results in stepwise accumulation of disability, including blindness and paralysis, and sometimes premature death,” it says.

Alexion says patients with AQP4 auto-antibodies represent about three quarters of all patients with NMOSD. Anti-AQP4 auto-antibody testing is available for diagnosing NMOSD, it adds.