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Japan approves Sanofi's Sarclisa subcutaneous formulation for multiple myeloma treatment

Market News
19 Jun 2026
Sanofi
View Source
Bullish
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Japan's Ministry of Health has approved Sanofi's Sarclisa (isatuximab) in a subcutaneous form for treating multiple myeloma, including newly diagnosed and relapsed/refractory cases. This approval follows positive results from the phase 3 IRAKLIA study, showing the subcutaneous version is as effective and safe as the intravenous form, with fewer infusion reactions. The subcutaneous formulation can be administered manually or via a portable on-body injector, potentially improving patient convenience. Sanofi is also seeking approval for this formulation in the US, marking a significant advance in multiple myeloma treatment options in Japan and globally.

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