Roche's Enspryng wins FDA approval for thyroid eye disease

Genentech, part of the Roche Group (RHHBY), said the FDA approved Enspryng (satralizumab-mwge) to treat adults with thyroid eye disease, making it the first and only at-home subcutaneous treatment option for the condition, according to a statement on Friday.

Patients or caregivers can administer the drug after receiving training from a healthcare provider. “Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” said Levi Garraway, chief medical officer and head of Global Product Development.

“As the first subcutaneous treatment for this condition, Enspryng offers a positive safety and efficacy profile and the potential for at-home administration.”

The totality of data from the pivotal Phase III SatraGO program (SatraGO-1 and SatraGO-2) provided clinically meaningful improvements in patients with TED.

Genentech said SatraGO-1 did not meet its primary efficacy endpoint at week 24, while SatraGO-2 showed significant and clinically meaningful improvements in proptosis response and diplopia reduction among patients with active thyroid eye disease. Proptosis response was 52.9% with Enspryng versus 23.4% with placebo, while diplopia reduction was 60.7% versus 25.8%. Consistent results were also observed in the overall SatraGO-2 population, which included patients with both active and chronic disease.

No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder.

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