Story perspectives

FDA OKs Subcutaneous Sarclisa; Cuts Reactions, Shares Slip

7/11/2026

Summary

FDA Approves Sarclisa

The FDA approved Sarclisa Escena (isatuximab-irfc) as a subcutaneous multiple myeloma drug delivered with the CirCLIQ injector.
Approval covers U.S. indications of the IV formulation and allows manual subcutaneous dosing.
In the phase 3 IRAKLIA trial, subcutaneous Sarclisa Escena achieved a 71.1% response rate versus 70.5% for IV, meeting non-inferiority.
Patients using the injector had 1.5% infusion-related reactions versus 25% with intravenous therapy, causing Sanofi shares to fall 0.82% to $43.54.

Summary

Sanofi Secures FDA

Sanofi secured FDA clearance for the Sarclisa Escena wearable injector, the first on-body cancer therapy, directly challenging Johnson & Johnson’s Darzalex.
CEO Belén Garijo presented the $8,796-per-vial injector, which administers treatment in a median 13-minute injection, diversifying Sanofi beyond Dupixent.
Sarclisa earned €588 million in 2025 and is projected to reach €710 million in 2026 under new R&D head Paulo Fontoura, who will expand the sub-cutaneous pipeline.

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FDA Approves Sarclisa

The FDA approved Sarclisa Escena (isatuximab-irfc) as a subcutaneous multiple myeloma drug delivered with the CirCLIQ injector.
Approval covers U.S. indications of the IV formulation and allows manual subcutaneous dosing.
In the phase 3 IRAKLIA trial, subcutaneous Sarclisa Escena achieved a 71.1% response rate versus 70.5% for IV, meeting non-inferiority.
Patients using the injector had 1.5% infusion-related reactions versus 25% with intravenous therapy, causing Sanofi shares to fall 0.82% to $43.54.

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