FDA 批准 Genentech 的 Enspryng 用于甲状腺眼病居家皮下治疗

First SC option offers new flexibility for patients

The FDA has approved Genentech’s Enspryng for adults with thyroid eye disease, making it the first at‑home subcutaneous treatment option for the condition. The therapy can be administered every four weeks during the maintenance phase by the person living with TED or a caregiver after appropriate training.

Levi Garraway 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.

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

César A Briceño explained: “Treating thyroid eye disease requires balancing efficacy, safety and the practical realities of long-term treatment.

“As a clinical trial investigator, I have seen firsthand the potential of targeted therapies such as Enspryng. The availability of an effective subcutaneous treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies.”

The approval is based on the phase 3 SatraGO programme. While SatraGO‑1 did not meet its primary endpoint at week 24, SatraGO‑2 showed significant improvements in proptosis response and diplopia reduction in the active TED population. No new safety signals were identified, with the profile consistent with that seen in neuromyelitis optica spectrum disorder.

Christine Gustafson said: “Thyroid eye disease not only affects a person’s eyes through bulging and vision problems, but it also takes a profound emotional toll on confidence, identity, relationships and daily life.

“Until now, our community has had very limited choices. The approval of Enspryng represents a critical turning point through a convenient, targeted option.”

The decision marks the second indication for Enspryng following its approval in neuromyelitis optica spectrum disorder in 2020. The medicine is also under priority review for myelin oligodendrocyte glycoprotein antibody‑associated disease and is being studied in additional autoimmune and inflammatory conditions.