Genentech announced June 30 that the US FDA had accepted its supplemental biologics license application (sBLA) for subcutaneous Enspryng (satralizumab) in thyroid eye disease (TED).

The agency granted priority review, with an expected decision date of Oct. 15, 2026.

Enspryng was approved in August 2020 as the first subcutaneous injection treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). It targets the IL-6 receptor, believed to play a key role in the inflammation that occurs in people with NMOSD and TED.

TED is a rare, debilitating autoimmune disorder characterized by inflammation and swelling of the tissues around the eyes, often leading to pain and vision impairment.

The first FDA-approved TED therapy was the infusion treatment Tepezza, now marketed by Amgen, which was launched in 2020. The FDA approved a second infusion drug for TED, Lumvoa (veligrotug-vvze) from Viridian Therapeutics, on June 29. Both target the insulin-like growth factor-1 receptor (IGF-1R), but Lumvoa features a shorter infusion time and fewer infusions compared with Tepezza.

Genentech, of South San Francisco, California, is among several companies—including Amgen and Viridian—developing subcutaneous TED candidates, eyeing more affordable and convenient home treatment and potentially fewer side effects.

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