Press Release: Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma

Sanofi announced approval of Sarclisa (isatuximab) subcutaneous formulation in Japan for multiple myeloma treatment in combination with standard-of-care regimens. This is the second global approval following EU authorization. The approval is based on the IRAKLIA phase 3 study demonstrating non-inferior efficacy and pharmacokinetics compared to intravenous formulation, with significantly fewer infusion reactions (1.5% vs 25%).