The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for satralizumab (Genentech) for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
Satralizumab is an investigational humanized monoclonal antibody that targets the interleukin-6 (IL-6) receptor which is believed to be a key driver of NMOSD, a complement-mediated disorder of the central nervous system. The BLA includes data from two phase 3, placebo-controlled studies, SAkuraStar (N=95) and SAkuraSky (N=83), which evaluated the safety and efficacy of satralizumab as monotherapy and in combination with baseline immunosuppressants, respectively.
In both studies, treatment with satralizumab resulted in a significant reduction in the risk of relapses compared with placebo in the overall study population of aquaporin-4 antibody (AQP4-IgG) seropositive and seronegative patients (SAkuraStar: HR=0.45, 95% CI: 0.23-0.89; P =.0184; SAkuraSky: HR=0.38, 95% CI: 0.16-0.88; P =.0184). Moreover, subgroup analysis showed an even greater reduction in relapse risk in AQP4-IgG seropositive patients (SAkuraStar: HR=0.26, 95% CI: 0.11-0.63; P =.0014; SAkuraSky: HR=0.21, 95% CI: 0.06-0.75; P =.0086).
“Satralizumab has shown robust efficacy sustained for 96 weeks and significantly reduced the risk of relapse across a broad patient population,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “We are working with the health authorities to make satralizumab available as soon as possible.”
Sartralizumab was previously granted Breakthrough Therapy designation. The Company expects an FDA decision on the application by 2020.
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