EU regulator backs Sanofi’s injectable version of blood cancer drug

March 27 (Reuters) – French drugmaker Sanofi said on Friday the European Medicines Agency has recommended the approval of a subcutaneous version of its blood cancer drug administered through an on-body injector.

Here are the details from the company’s statement:

* EMA’s positive opinion for Sanofi’s drug Sarclisa was onthe basis of late-stage trials which showed the subcutaneousversion demonstrated non-inferiority compared with theintravenous formulation. * Sarclisa was first approved in the EU in 2020 for treatingmultiple myeloma, a rare blood cancer that starts in the bonemarrow, where abnormal white blood cells multiply uncontrollablyand produce faulty proteins. * If approved in its new formulation, the drug would beadministered via an injector worn on the skin to deliver themedication over time. * Sanofi said the European Commission, which usually followsthe EMA’s recommendation, is expected to make a final decisionin the coming months. * Sarclisa brought in 588 million euros ($677.14 million) insales in 2025. * The U.S. Food and Drug Administration is also reviewingthe company’s application for the subcutaneous on-body injectorversion of the drug. * ($1 = 0.8684 euros)

(Reporting by Christy Santhosh in Bengaluru; Editing by Leroy Leo)