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

March 27 (Reuters) - French drugmaker Sanofi SASY.PA 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 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.

• ($1 = 0.8684 euros)