Sanofi's multiple myeloma drug Sarclisa (isatuximab) has received European Union approval for a subcutaneous on-body injector formulation, becoming the first cancer therapy delivered via a wearable injector. This regulatory milestone signals a shift in oncology drug delivery that could influence how medical aesthetics clinics and distributors approach patient-friendly, at-home treatment systems.
Regulatory milestone
The European Commission approved Sarclisa's manual subcutaneous injection and on-body injector for all indications previously covered by intravenous administration. The decision is based on the Phase 3 IRAKLIA study in relapsed/refractory multiple myeloma. This marks the first time a cancer drug has been authorized for delivery via a body-worn injector, potentially setting a precedent for other therapeutic areas including aesthetic medicine.
Device technology
The on-body injector uses the CirCLIQ auto-injector based on Enable Injections' enFuse platform. Patients attach the wearable device to their skin and press a button for automatic subcutaneous drug delivery. Unlike insulin pumps, this device administers a fixed dose in a single session. The technology could inspire similar delivery systems for aesthetic injectables, offering convenience and precision.
Clinical data highlights
The IRAKLIA study demonstrated non-inferiority: objective response rate was 70.5% for IV versus 71.1% for the on-body injector. Drug infusion-related adverse events were significantly lower with the on-body injector (1.5%) compared to IV (25%). Patient satisfaction was higher with the on-body injector (70% satisfied or very satisfied) versus IV (53.4%). Both patients and healthcare providers preferred the on-body injector.
Market implications
This approval positions Sarclisa to compete more closely with Johnson & Johnson's Darzalex, as the on-body injector enables self-administration outside hospitals or with reduced healthcare provider supervision. The trend toward reducing hospital stays and enabling home-based treatment aligns with broader healthcare shifts. For medical aesthetics buyers, this signals growing regulatory acceptance of wearable injectors, potentially opening opportunities for similar devices in aesthetic applications.
Sourcing context
Despite EU approval, Sarclisa's on-body injector is unlikely to enter the South Korean market due to prior reimbursement challenges for the IV formulation. This highlights the importance of regulatory and reimbursement pathways in different regions. Distributors and clinics should monitor how such device-drug combinations gain market access, as similar hurdles may apply to aesthetic injectable devices.
Source: Read the original report | Published: September 04, 2025