FDA Clears Roche’s Enspryng for Thyroid Eye Disease
The approval makes Enspryng an at-home subcutaneous treatment option, while trial results differed between the two Phase III studies.
Key takeaways
- The FDA approved Enspryng for adults with thyroid eye disease.
- SatraGO-2 showed improvements in eye bulging and double vision.
- SatraGO-1 did not meet its primary efficacy endpoint at Week 24.
The FDA approved Roche’s Enspryng for adults with thyroid eye disease, giving patients the first and only at-home subcutaneous treatment option for the condition, Roche said.
Patients or caregivers can administer the medicine after training from a healthcare provider. Roche said it is given every four weeks during the maintenance phase.
Results from the Phase III program were mixed. SatraGO-1 did not meet its primary efficacy endpoint at Week 24, while SatraGO-2 showed significant improvements in eye bulging and double vision compared with placebo.
In SatraGO-2’s active disease group, 52.9% of patients receiving Enspryng had an improvement in eye bulging, versus 23.4% on placebo. Reduction in double vision was reported for 60.7% of the Enspryng group and 25.8% of the placebo group.
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