FDA clears supplemental efficacy application for Genentech's Enspryng
The agency approved an eighth supplement to satralizumab's biologics license, according to FDA records dated October 15, 2026.
The U.S. Food and Drug Administration approved supplement 8 to the biologics license application for Enspryng, Genentech's brand name for satralizumab, with a submission status date of October 15, 2026, according to FDA drug approval records.
The filing is listed under application number BLA761149 and carries a submission class of "Efficacy."1 The FDA designated the review priority as "PRIORITY."1
The product is formulated as an injectable solution. Records describe it as an injection route product containing satralizumab at a strength of 120MG/ML.1
Genentech is listed as the sponsor of the application.1
An approval letter tied to the submission is dated October 19, 2026, per the FDA's application documents listing, though the broader submission status date in the same record is listed as October 15, 2026. The documents do not specify the clinical content or indication change associated with this particular supplement. No additional detail on trial data, dosing changes, or labeling updates tied to this supplement is included in the available record.
Further specifics, including any changes to prescribing information or clinical trial results supporting the supplement, were not included in the FDA record reviewed for this report.
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