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# Complete Response Letter on Ultomiris sBLA
- URL: https://www.fdaweb.com/complete-response-letter-on-ultomiris-sbla/
- Published: 2023-09-06T12:00:00.000Z
- Updated: 2026-09-14T18:54:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155261

FDA has issued AstraZeneca’s Alexion unit a complete response letter (CRL) on a supplemental BLA for long-acting C5 complement inhibitor Ultomiris(ravulizumab-cwvz). The suupplent sought expanded use in treating adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive (Ab+). The company says the CRL “requested modifications to enhance the Ultomiris Risk Evaluation and Mitigation Strategy (REMS) to further validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics prior to treatment.” It further notes that the letter did not request any additional analyses of the Phase 3 CHAMPION-NMOSD trial data included in the submission and did not raise concerns about efficacy or safety data.

Ultomirisiscurrently FDA approved for treating adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor Ab+, and certain adults and children with paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome.