Sanofi's Sarclisa SC Recommended for EU Approval

Sanofi's Sarclisa subcutaneous (SC) formulation, administered via an on-body injector, has been recommended for EU approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The recommendation is based on positive results showcasing the efficacy, pharmacokinetics, and safety of the SC formulation compared to the intravenous version.

If approved, Sarclisa SC will be the first anticancer treatment available through an on-body injector and as a manual injection in the EU. The CHMP's positive opinion follows findings from the IRAKLIA phase 3 study, demonstrating non-inferiority of the SC formulation, backed by four additional studies.

The studies utilized Enable Injections’ enFuse® injector, designed to deliver high-volume medications subcutaneously, potentially improving patient comfort and satisfaction. Sarclisa is currently approved in various countries for multiple myeloma treatment in several formulations.