Roche Gets FDA Approval for Enspryng to Treat Thyroid Eye Disease
By Adria Calatayud
Roche Holding said it received approval from the U.S. Food and Drug Administration to market its Enspryng drug as a treatment for rare autoimmune condition thyroid eye disease in adults.
The Swiss drugmaker said this marks the second indication in the U.S. for Enspryng, which was already authorized in 2020 for autoimmune disease neuromyelitis optica spectrum disorder.
The FDA approval for Enspryng in thyroid eye disease was based on the results of two late-stage studies, the company said.
The regulator is reviewing another application for myelin oligodendrocyte glycoprotein antibody-associated disease, and Roche said it is evaluating the drug in additional neurological autoimmune and inflammatory diseases.
Write to Adria Calatayud at adria.calatayud@wsj.com
(END) Dow Jones Newswires
October 16, 2026 01:27 ET (05:27 GMT)
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