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FDA accepts biologics license application for satralizumab
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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 combination with baseline immunosuppressant therapy.
“People living with NMOSD experience unpredictable relapses that can cause permanent neurological damage, and although there have been significant strides recently in understanding the disease, more approved options are needed with different treatment approaches. Satralizumab has shown robust efficacy sustained for 96 weeks and significantly reduced the risk of relapse across a broad patient population, while offering self-administered subcutaneous dosing every 4 weeks,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.
The FDA decision and the EMA’s Committee for Medicinal Products for Human Use recommendation are both expected in 2020, the release said.