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EU regulator backs Sanofi's injectable version of blood cancer drug
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EU regulator backs Sanofi's injectable version of blood cancer drug
Mar 27, 2026 6:54 AM

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 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)

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