Enable Injections’ On-Body Injector Wins FDA Nod to Deliver Sanofi Anticancer Drug

Enable Injections’ CirCLIQ on-body injector (OBI) has obtained U.S. Food and Drug Administration (FDA) approval to administer drugmaker Sanofi’s subcutaneous Sarclisa (isatuximab-irfc) Escena, combined with standard-of-care regimens, to treat multiple myeloma patients.

(Sarclisa is currently approved across three indications in the U.S., including in combination with bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma (NDMM) patients not eligible for autologous stem cell transplant.)

According to Sanofi, Sarclisa Escena is now the first anticancer treatment that can be delivered through both an OBI and manual subcutaneous administration. The pivotal IRAKLIA phase 3 non-inferiority study supporting this FDA approval showed the medication delivered subcutaneously with an OBI was similar in efficacy, pharmacokinetics, and safety compared to intravenous (IV) infusion.

There was also much shorter treatment duration and fewer reactions related to infusion using the OBI, according to the study. Sikander Ailawadhi, MD, Professor of Medicine, Division of Hematology/Oncology at Mayo Clinic Florida, US, and the principal investigator of the IRAKLIA study said this is important because treating multiple myeloma often requires frequent IV infusions or manual subcutaneous injections.

Treatment administration can be a cumbersome experience for patients, while also placing a strain on providers by requiring physical effort to push high-resistance syringes for several minutes,” Dr. Ailawadhi told the press. “The comparable efficacy observed across multiple studies and the patient-centric design of the OBI offers an opportunity to impact the patient experience while upholding Sarclisa’s consistent efficacy.”

Enable Injections’ hands-free on-body injector delivers high-volume medicines subcutaneously by pushing a button. Its retractable, 30g needle is shorter and thinner than needles usually used for large-volume injections, the company claims. Enable hopes combining Sarclisa Escena with its CirCLIQ OBI—built using the enFuse platform—will revolutionize multiple myeloma treatment.

“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,” said Manuela Buxo, executive VP and head of Specialty Care at Sanofi. “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.”

Last month, Enable Injections announced a strategic partnership, which named Aptar Digital Health as its preferred digital health partner for the enFuse system. The digital solution will aim to guide patients and caregivers throughout the injection process and help support engagement before, during, and after administration.