Drugs and FDA
FDA approves Enspryng as an at-home treatment for thyroid eye disease
Enspryng is FDA-approved for at-home injection to treat thyroid eye disease in adults, with patient or caregiver administration after provider training.
The FDA approved satralizumab (Enspryng) as an at-home subcutaneous treatment for adults with thyroid eye disease, Roche announced. It is the first at-home subcutaneous treatment approved for the condition. Patients or caregivers can give the injections after training from a healthcare provider.
The approval was supported by the SatraGO-1 and SatraGO-2 trials. In SatraGO-2, 52.9% of patients taking Enspryng had a reduction of at least 2 mm in proptosis, compared with 23.4% taking placebo. Diplopia reduction occurred in 60.7% and 25.8%, respectively. SatraGO-1 missed its prespecified primary efficacy endpoint at week 24. The first three doses are given at weeks 0, 2, and 4, followed by injections every 4 weeks. Roche said the drug’s safety profile was consistent with its known profile in neuromyelitis optica spectrum disorder.
