The FDA has accepted a biologics license application for satralizumab for the treatment of neuromyelitis optica spectrum disorder, Genentech/Roche announced in a press release.
A marketing authorization application for the drug has also been validated by the European Medicines Agency, which granted the treatment for accelerated assessment.
Both applications are based on positive results from the SAkuraStar and SAkuraSky phase 3 studies evaluating the safety and efficacy of satralizumab, a humanized monoclonal antibody that targets the interleukin-6 receptor, as both monotherapy and in
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