French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) on Thursday announced positive results from the IRAKLIA phase 3 study evaluating Sarclisa administered subcutaneously (SC) via an on-body delivery system (OBDS) in combination with pomalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma.

The study met its co-primary endpoints of non-inferior objective response rate (ORR) and observed concentration before dosing (C trough) at steady state compared to intravenous (IV) Sarclisa. Key secondary endpoints were also achieved.

IRAKLIA used Enable Injections' enFuse OBDS, designed for the subcutaneous administration of high-volume medicines.

Regulatory submissions for Sarclisa SC are planned for the United States and the European Union in the first half of 2025.