FDA Approves Enspryng for Thyroid Eye Disease

First At-Home Thyroid Eye Disease Shot Approved

(MedPage Today) -- The FDA approved satralizumab (Enspryng), the first and only at-home subcutaneous treatment option for adults with thyroid eye disease (TED), developer Roche announced on Thursday. The first-in-class drug is a humanized monoclonal...

FDA approves Enspryng for thyroid eye disease

The FDA approved Enspryng, an interleukin-6 inhibitor, for at-home subcutaneous treatment of thyroid eye disease, according to a press release from Genentech.

FDA clears Roche's Enspryng for thyroid eye disease

Roche has claimed US approval for Enspryng in a second indication, thyroid eye disease, that makes it a rival to drugs from Amgen and Viridian.

FDA Approves Enspryng (Satralizumab) for Thyroid Eye Disease

The interleukin-6 receptor inhibitor gains a second indication, though one of two phase 3 trials missed its primary endpoint.

FDA Approves Genentech's Enspryng as First At-Home Subcutaneous Treatment for Thyroid Eye Disease

Key Takeaways The FDA approved Enspryng as the first at-home subcutaneous treatment for adults with thyroid eye disease The approval follows a priority review and is supported by results from the phase 3 SatraGO clinical program, which demonstrated improvements in proptosis and diplopia No new safety signals were identified, and at-home administration may reduce treatment burden The FDA has approved Genentech’s Enspryng (satralizumab-mwg…

Roche Secures FDA Approval for At-Home Enspryng Treatment of Thyroid Eye Disease

The FDA decision draws on Phase III SatraGO findings, including significant proptosis and double-vision improvements in SatraGO-2, while SatraGO-1 missed its primary endpoint. IN BRIEFKEY TAKEAWAYSFAQs Roche has announced U.S. FDA approval of Enspryng (satralizumab) for adults with thyroid eye … Read the full press release →