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Roche gets U.S. approval for Enspryng, takes on Alexion's Soliris


ZURICH (Reuters) - The U.S. Food and Drug Administration on Saturday approved Roche's Enspryng for the central nervous system disorder neuromyelitis optica, putting the Swiss drugmaker head-to-head with Alexion's Soliris in a costly treatment area.

Enspryng, also known by its generic name satralizumab, is already approved in Japan and comes as a shot that people can give to themselves. The wholesale acquisition cost for Enspryng is just under $220,000 for the first year when 15 doses are needed, and $190,000 for subsequent years when 13 doses are required, Roche said.

It will go up against Alexion's drug Soliris, an infusion listed at up to around $500,000 annually, for adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive.

Neuromyelitis optica, sometimes mistaken for multiple sclerosis, is an autoimmune disease that attacks nerves in the eye and spinal cord. It affects some 25,000 people in Europe and the United States, and 200,000 worldwide.

Enspryng, a modified version of Roche's drug Actemra that was also developed by the company's Japanese unit Chugai, is designed to inhibit cytokines that play a role in inflammation.

Roche has been expanding its portfolio beyond cancer drugs, and its portfolio now includes Ocrevus, it's $4 billion-per-year multiple sclerosis medicine, recently approved Evrysdi for the genetic disease spinal muscular atrophy, and hemophilia drug Hemlibra.

(Reporting by John Miller; Editing by Christina Fincher)

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