The European Medicines Agency (EMA) has issued a positive opinion regarding the subcutaneous formulation of Sarclisa (isatuximab) from French drugmaker Sanofi, Reuters reports. The drug is intended for the treatment of multiple myeloma. If approved, patients will be able to administer the new version using an on-body injector that provides gradual release of the active substance.
The recommendation is based on late-stage clinical trial results showing that the subcutaneous version demonstrated non-inferiority compared with the intravenous formulation. Sarclisa was first approved in the EU in 2020 for the treatment of multiple myeloma—a rare blood cancer that starts in the bone marrow, where abnormal white blood cells multiply uncontrollably.
A final decision on approval is expected from the European Commission in the coming months, which typically follows the EMA’s recommendation. In 2025, Sarclisa generated €588 million in sales. The application for the subcutaneous version is also under review by the US Food and Drug Administration.
