Key takeaways:

• Enspryng is the first at-home subcutaneous treatment approved for TED.
• The approval is supported by findings from the phase 3 SatraGO program.

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

Enspryng is an IL-6 inhibitor that was previously approved for neuromyelitis optica spectrum disorder.

The approval was supported by findings from the phase 3 SatraGO program in thyroid eye disease (TED). In patients with active and chronic moderate to severe TED, the SatraGO-2 trial demonstrated a “significant and clinically meaningful difference” of 52.9% in proptosis response and 60.7% in diplopia reduction with Enspryng vs. 23.4% and 25.8%, respectively, in the placebo group. The SatraGO-1 trial missed its prespecified primary efficacy endpoint at week 24, according to the release.

In both trials, the safety of Enspryng (satralizumab-mwge, Genentech/Roche) was consistent with its known profile in neuromyelitis optica spectrum disorder.

Enspryng can be administered by patients or caregivers after training from a healthcare provider, making it the first at-home subcutaneous treatment approved for TED, the release said.

“Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the release. “As the first subcutaneous treatment for this condition, Enspryng offers a positive safety and efficacy profile and the potential for at-home administration.”

Enspryng is the third FDA-approved treatment for TED, alongside Tepezza (teprotumumab-trbw, Amgen) and Lumvoa (veligrotug-vvze, Viridian). It is also indicated for the treatment of neuromyelitis optica spectrum disorder.