Overview
- The U.S. Food and Drug Administration approved Sarclisa Escena, a subcutaneous version of Sanofi’s isatuximab, to be delivered using Enable Injections’ on-body system branded CirCLIQ/enFuse.
- The subcutaneous form is cleared for the same multiple myeloma indications as the existing intravenous Sarclisa, allowing use in combination with standard-of-care regimens.
- Sanofi invested in Enable Injections and ran studies to support the filing, and plans to offer the wearable device in the U.S.
- The enFuse/CirCLIQ system is a hands-free, hidden-needle on-body injector designed to deliver large-volume biologics subcutaneously using a retractable fine needle.
- Clinics and patients are expected to see shorter visits and reduced nursing burden from the switch to wearable dosing, and the approval reflects a wider industry trend toward converting IV biologics to patient-friendly subcutaneous formats.