FDA approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

August 17, 2020 – Roche (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) has approved 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). NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis.

ENSPRYNG is a humanized monoclonal antibody and the only approved therapy designed to target and inhibit interleukin-6 (IL-6) receptor activity, believed to play a key role in the inflammation associated with NMOSD. The treatment was designed by Chugai, a member of the Roche group, using novel recycling antibody technology, which compared to conventional technology, allows for longer duration of antibody circulation and subcutaneous dosing every four weeks.

ENSPRYNG can be administered in the home by a person living with NMOSD or a caregiver following training from a healthcare provider. ENSPRYNG treatment is administered every four weeks after an initial loading dose.

ENSPRYNG will be available in the United States in two weeks.

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