FDA approves Sarclisa Escena, a new dosage form from Sanofi
The agency cleared BLA761445 for isatuximab-irfc under the brand name Sarclisa Escena, with an original approval dated July 9, 2026.
The FDA has approved a new biologics license application from Sanofi-Aventis U.S. LLC for a product named Sarclisa Escena, containing the active ingredient isatuximab-irfc at a strength of 1400MG/10ML (140MG/ML)1. The product is supplied as a single-dose vial.
The submission was classified as a Type 3 - New Dosage Form application1, filed under original submission number 1. The application carried a standard review priority1, and its status is recorded as approved, with a submission status date of 2026-07-091.
FDA records list two application documents tied to this approval. A corrected approval letter is dated July 13, 2026, and the product label is dated July 15, 2026, according to application document filings hosted on the FDA's drug approval database1.
The approval covers Sarclisa Escena as marketed by Sanofi-Aventis U.S. LLC, expanding the isatuximab-irfc product line with a new dosage form under the Sarclisa brand family. No additional details on indication, dosing schedule, or clinical trial data supporting this specific approval were included in the FDA filing record reviewed.
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