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FDA OKs Genentech’s Enspryng for nervous system disorder

August 17, 2020

The FDA has approved Roche (OTCQX:RHHBY) unit Genentech’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 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.

Enspryng will be available in the U.S. in two weeks. It is also approved in Canada, Japan and Switzerland. Applications are under review with numerous regulators, including in the European Union and China.

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