FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the 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.
“Today’s FDA approval of Enspryng, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with Ocrevus to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We thank the NMOSD community, including patients and investigators who participated in Enspryng clinical trials.”
Enspryng is a humanized monoclonal antibody and the approved therapy for NMOSD 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 using novel recycling antibody technology, which, compared to conventional technology, allows for longer duration of antibody circulation and subcutaneous dosing every four weeks.
“For people with NMOSD, relapses can cause devastating, irreversible and disabling neurological effects,” said Professor Jeffrey Bennett, University of Colorado Neurology & Ophthalmology, and investigator for the Enspryng pivotal clinical trials. “Having an approved therapy that can be administered subcutaneously in the home and has demonstrated an impact on the frequency of relapses is an important advancement for patients.”
“We are very optimistic the addition of this new approved treatment option will make a meaningful difference for those living with NMOSD, those who love and support them and the doctors who treat them,” said Victoria Jackson, founder, The Guthy-Jackson Charitable Foundation. “When my daughter was diagnosed with NMOSD in 2008, there were no approved treatment options, and a critical lack of resources and understanding for people living with this disabling disorder. After years of dedicated effort and collaboration, the FDA approval of Enspryng exemplifies how patients, industry, and academia can find solutions together.”
Enspryng from Genentech 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.
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