Sanofi's Sarclisa Gets EMA Nod for Subcutaneous On-Body Injector Version

EMA's positive opinion for Sanofi's ​drug Sarclisa was on the basis of late-stage trials which ​showed the subcutaneous version demonstrated non-inferiority compared with the intravenous formulation.

Sarclisa was first ​approved in the EU ⁠in 2020 ‌for treating multiple myeloma, a ​rare ​blood cancer that starts in ⁠the bone marrow, where abnormal white blood cells ​multiply uncontrollably and produce faulty proteins.

If approved in its new formulation, the drug would be administered via an injector worn on the skin to deliver the medication over time.

Sanofi ‌said the European Commission, which usually follows the EMA's recommendation, is expected ​to ​make a ⁠final decision in the coming months. Sarclisa brought in 588 million euros ($677.14 million) in sales in 2025.

The ​U.S. Food and Drug Administration is also reviewing the company's application for the subcutaneous on-body injector version of the drug.

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