CHGCY - Chugai's Enspryng approved in Taiwan for the treatment of nervous system disorder
Chugai Pharma Taiwan, a wholly-owned subsidiary of Chugai Pharmaceutical (CHGCY) has obtained an import drug license approval from the Taiwan Food and Drug Administration ((TFDA)) for it’s Enspryng (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder ((NMOSD)), a rare, debilitating autoimmune disorder of the central nervous system that primarily damages the optic nerve(s) and spinal cord.Enspryng, designed by Chugai, is a humanized monoclonal antibody designed to target and inhibit interleukin-6 (IL-6) receptor activity, which is believed to play a key role in the inflammation associated with NMOSD.The approval is based on the results from 2 global phase III SAkuraSky Study clinical studies which showed reduced risk of relapse in people with NMOSD. SAkuraSky is a study to evaluate Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar is a study to evaluate Enspryng as monotherapy.
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Chugai's Enspryng approved in Taiwan for the treatment of nervous system disorder