Sanofi has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for a subcutaneous (injectable) version of its blood cancer drug, Sarclisa.

The subcutaneous formulation is designed to be administered using an on-body injector, providing an alternative route of administration to the currently approved intravenous formulation. The move is aimed at expanding administration options for the therapy.

The CHMP’s positive opinion marks a key regulatory step, and the recommendation will now be reviewed by the European Commission, which is expected to take a final decision on approval in the coming months.

Sarclisa is indicated for the treatment of multiple myeloma, a type of blood cancer, and is part of Sanofi’s oncology portfolio.

Sanofi also stated that the US Food and Drug Administration (FDA) is reviewing the application for the subcutaneous version of Sarclisa, indicating parallel regulatory progress in the US market.

The injectable version is intended to complement the existing formulation by offering an alternative delivery method through an on-body system.

Sarclisa generated €588 million in sales in 2025.

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