FDA grants priority review to Satralizumab sBLA for thyroid eye disease

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.