French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Monday that it has received European Commission approval for subcutaneous Sarclisa (isatuximab) for multiple myeloma across all existing indications currently approved for the intravenous formulation in the European Union.

Sarclisa is the first anticancer therapy in the EU to be administered through an on-body injector (OBI) and the first multiple myeloma treatment available via both subcutaneous OBI and manual injection, enabling administration in home and outpatient settings.

The approval is supported by results from the Phase 3 IRAKLIA study, which demonstrated non-inferiority of the subcutaneous formulation versus intravenous administration, with objective response rates of 71.1% and 70.5%, respectively, in relapsed or refractory multiple myeloma patients.

Data from the IRAKLIA and IZALCO studies indicated higher patient satisfaction and preference for OBI administration, with 74.5% of patients in IZALCO preferring the OBI over manual injection.

Sarclisa subcutaneous will be administered using Enable Injections' CirCLIQ OBI, an automated injector developed on the enFuse platform.

The safety profile of Sarclisa SC-Pd was consistent with the intravenous formulation, while systemic infusion reactions occurred in 1.5% of patients receiving the subcutaneous treatment compared with 25% of those receiving intravenous therapy.

In countries where home administration was permitted, median injection duration was 13 minutes in both clinic and home settings, with all home injections completed and no new safety signals reported.