The resubmission is considered a Class 1 submission and has a current PDUFA target action date of July 29, 2026.
News|Articles|June 30, 2026
FDA grants priority review to Satralizumab sBLA for thyroid eye disease
Author(s)Ophthalmology Times Staff
Fact checked by: Lucia Gambuzza
The FDA has granted priority review to satralizumab for thyroid eye disease, with a PDUFA date of October 15, 2026, based on phase 3 SatraGO trial data.
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The US FDA has accepted and granted priority review to a supplemental Biologics License Application (sBLA) from Genentech for satralizumab (Enspryng; Genentech) for the treatment of thyroid eye disease (TED), with a PDUFA target date of October 15, 2026. If approved, satralizumab would represent the first subcutaneous, at-home treatment option for TED and the first IL-6 receptor inhibitor approved in the indication.
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