FDA Grants Priority Review To Genentech’s Application for Enspryng, the First and Only At-Home Subcutaneous Treatment Option for Thyroid Eye Disease (TED)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED). The filing acceptance is based on results from the two randomized, placebo-controlled global Phase III SatraGO studies assessing the safety and ef