PARIS (dpa-AFX) - French drug major Sanofi SA (SNYNF, SNY) announced Friday that the US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa Escena administered via the CirCLIQ on-body injector (OBI) for the treatment of patients with multiple myeloma (MM).
With the approval, Sarclisa Escena is the first anticancer treatment to be administered through OBI, and first MM treatment available by both SC OBI and manual SC administration in the US.
The FDA approval was supported by multiple studies, including the pivotal IRAKLIA phase 3 non-inferiority study, which demonstrated Sarclisa Escena administered subcutaneously via an OBI provided similar efficacy, pharmacokinetics and safety compared to IV infusion, along with a significantly shorter treatment time and fewer infusion-related reactions.
The studies were conducted using Enable Injections' hands-free OBI, an automated injector designed to deliver subcutaneously high-volume medicines with the push of a button, to administer Sarclisa Escena.
The OBI uses a retractable 30g needle that is shorter and thinner compared to the needles commonly used for large-volume injections. The approval of Sarclisa Escena with Enable Injections' CirCLIQ OBI - developed using the enFuse platform - offers the potential to change the overall patient experience in MM treatment.
In addition, the CirCLIQ may streamline the administration process for providers, offering the potential to reduce the physical burden on nurses with a hands-free device and providing more freedom for patient monitoring and interaction.
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