Roche Holding AGFDA priority review for Enspryng, a Roche subsidiary's drug, increases approval likelihood

The U.S. Food and Drug Administration has accepted and granted priority review to Genentech’s supplemental Biologics License Application for Enspryng as a treatment for thyroid eye disease, with a decision expected by October 15, 2026. The application is based on results from the two global Phase III SatraGO studies, in which Enspryng demonstrated clinically meaningful improvements in proptosis and diplopia. In the SatraGO-2 trial, 53% of patients treated with Enspryng achieved a proptosis reduction at week 24 compared to 23% on placebo, while in SatraGO-1 the response rates were 49% versus 31%. Enspryng also improved clinical activity score in 78% to 90% of patients and reduced double vision in 44% to 61% across the two studies. If approved, Enspryng would become the first at-home subcutaneous treatment option for thyroid eye disease, which affects approximately 155 out of every 100,000 people.
Roche Holding AGFDA priority review for Enspryng, a Roche subsidiary's drug, increases approval likelihood
Advanced Micro Devices Inc
Roper Technologies IncFDA priority review for Genentech's Enspryng for thyroid eye disease