Enable Injections’ on-body delivery device [Photo courtesy of Enable Injections]Sanofi announced today that the FDA approved the delivery of its Sarclisa anticancer therapy through the Enable Injections on-body device.
Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens received clearance for the treatment of patients with multiple myeloma (MM) across all existing indications of the Sarclisa intravenous (IV) formulation. Approval makes it the first anticancer treatment administered through an on-body injector and manual subcutaneous administration.
Earlier this year, Sanofi invested $30 million in Enable Injections as the companies conducted a study to accelerate Sarclisa approval. Now, they can offer the Sarclisa-delivering device — branded as CirCLIQ — in the U.S.
Cincinnati-based Enable develops its syringe transfer system for drug delivery. The on-body delivery system, provides subcutaneous abdominal bolus administration of drug or biologic products in accordance with the drug product requirements. The mechanical, wearable device can deliver large volumes of small-molecule and biologic medications subcutaneously. Patients can receive their needed treatment in a single injection under the skin, rather than the intravenous route.
Enable Injections designed enFuse to streamline and improve in-clinic or patient self-administration. enFuse features hands-free, hidden-needle drug delivery. It uses a retractable 30g needle that registers shorter and thinner than common needles used for large-volume injections.
The system received FDA approval for the delivery of Empaveli in October 2023, then CE mark last year. The company also has partnerships with companies such as Roche and Serina Therapeutics.
Sanofi and Enable Injections also say that CirCLIQ can streamline the administration process for providers. It could reduce the physical burden on nurses with a hands-free device and offer more freedom for patient monitoring and interaction.
Manuela Buxo, EVP, head of Specialty Care at Sanofi, said:
“Sarclisa is the cornerstone of our oncology franchise, and we have always been confident in it being widely adopted as a potential best-in-class therapy. The approval of Sarclisa Escena subcutaneous formulation administered with the CirCLIQ is a definitive step in this direction. More than 70,000 patients worldwide have benefitted from Sarclisa, delivering predictable and important efficacy and safety across multiple combinations and lines of therapy. Today, we are proud to bring innovation that will empower physicians to enhance the treatment experience for patients, offering greater simplicity, flexibility and convenience.”