Roche's Genentech wins FDA approval for Enspryng to treat thyroid eye disease
Genentech received FDA approval for Enspryng to treat adults with thyroid eye disease, making it the first and only at-home subcutaneous treatment for the condition. In SatraGO-2, proptosis response was 52.9% with Enspryng versus 23.4% with placebo, while SatraGO-1 missed its primary efficacy endpoint at week 24.
1. FDA approves Enspryng
Roche unit Genentech secured FDA approval for Enspryng to treat adults with thyroid eye disease. It is the first and only at-home subcutaneous treatment for the condition, administered by patients or caregivers after training.
2. Trial results
In SatraGO-2 among patients with active disease, proptosis response reached 52.9% with Enspryng versus 23.4% with placebo, and diplopia reduction reached 60.7% versus 25.8%. SatraGO-1 missed its prespecified primary efficacy endpoint at week 24; neither trial identified new safety signals.
