Brussels greenlights subcutaneous administration for Sanofi's Sarclisa
Sanofi has announced that the European Commission has approved the subcutaneous (SC) formulation of Sarclisa (isatuximab), in combination with standard-of-care regimens, for the treatment of patients with multiple myeloma (MM) across all existing indications of the intravenous (IV) formulation.
The healthcare group emphasized that this decision makes Sarclisa the first cancer treatment in the EU to be administered via a wearable injector and manual SC injection, 'offering administration flexibility in patients' homes or outpatient settings'.
The approval of Sarclisa SC is based on results from the pivotal Phase 3 IRAKLIA study in relapsed and/or refractory (R/R) multiple myeloma, which demonstrated the non-inferiority of the SC formulation compared to the IV route, as well as on supplementary studies.
The IRAKLIA and IZALCO studies suggest that the use of an on-body injector (OBI) may be associated with greater simplicity, flexibility, convenience, and patient satisfaction compared to IV administration, and that patients and healthcare professionals prefer the OBI over manual SC administration.
Sarclisa will be used in conjunction with Enable Injections' CirCLIQ wearable injector, an automated device developed using the enFuse platform, designed to deliver Sarclisa subcutaneously at the push of a button in outpatient or home settings.
Among patients in countries where home administration was authorized, the median injection time for Sarclisa SC via a wearable injector was identical between clinic and home administration (13 minutes).
Sanofi is the largest European pharmaceutical group. Net sales by family of products break down as follows:
- pharmaceutical products (81.8%): prescription drugs for the treatment of multiple sclerosis, neurological diseases, inflammatory diseases, autoimmune diseases, rare diseases, cancers and rare hematological diseases;
- human vaccines (18.2%): pediatric vaccines, vaccines for flu, meningitis, and polio, booster vaccines, and vaccines for travelers and endemic areas.
At the end of 2025, the group had 37 production sites worldwide.
Net sales are distributed geographically as follows: France (3.9%), Europe (17.1%), the United States (50.8%), China (6%) and other (22.2%).
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