Sanofi received approval from Japan’s Ministry of Health, Labour and Welfare for the subcutaneous formulation of Sarclisa. This isatuximab injection treats both relapsed or refractory and newly diagnosed multiple myeloma.
The approval marks the second global clearance for this administration method following the European Union. The subcutaneous version reduces treatment burden compared to traditional intravenous delivery.
The Phase 3 IRAKLIA study supported the decision, demonstrating comparable efficacy to the intravenous version with a favorable safety profile.
Japan is also reviewing a regulatory submission for an on-body injector. If cleared, Sarclisa would become the first anticancer therapy in Japan administered via this device.