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# Genentech BLA Submitted for Satralizumab
- URL: https://www.fdaweb.com/genentech-bla-submitted-for-satralizumab/
- Published: 2019-10-31T12:00:00.000Z
- Updated: 2026-09-14T15:51:23.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145388

FDA has accepted for review a Genentech BLA for satralizumab for treating adults and adolescents with neuromyelitis optica spectrum disorder. The rare, debilitating autoimmune disease of the central nervous system primarily damages the optic nerves and spinal cord, which can cause blindness, muscle weakness and paralysis. Those with the disorder experience unpredictable relapses that can cause permanent neurological damage, according to the company.

The submission is based on positive results from two Phase 3 studies, SAkuraStar and SAkuraSky, that evaluated satralizumab as a monotherapy and in combination with baseline immunosuppressant therapy. In the SAkuraStar study, satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo, Genentech says. In the SAkuraSky study, combination therapy showed a 62% reduction in the risk of relapses compared to placebo, it adds. Regarding safety, the company says that patients with serious adverse events were similar between the satralizumab and placebo treatment groups in both studies.