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FDA approves Roche’s Enspryng for neuromyelitis optica

Published on 17/08/20 at 10:27am

The FDA has granted approval for Roche’s Enspryng for treating the central nervous system disorder neuromyelitis optica.

The drug (satralizumab) has already been approved in Japan as a shot patients can administer themselves. Roche said the treatment will cost $220,000 for the first year where 15 doses are required, and $190,000 for the second year for 13 doses. Although a relatively expensive treatment, it will compete with Alexion’s drug for the same condition that costs around $500,000 for doses that cover a year.

Neuromyelitis optica is often mistaken for multiple sclerosis, and is an autoimmune disease that attacks nerves in the eyes and the spinal cord. It affects about 200,000 people across the world. Roche’s drug is designed to inhibit the cytokines that play a role in the inflammation this disease causes.

Levi Garraway, Roche’s Chief Medical Officer and head of global product development, said: “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. We thank the NMOSD community, including patients and investigators who participated in Enspryng clinical trials.”

Conor Kavanagh

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