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)