The U.S. Food and Drug Administration announced on Friday that it has approved a wearable form of Sanofi’s multiple myeloma therapy Sarclisa, authorizing subcutaneous administration via an on-body injector. The newly approved delivery format - branded Sarclisa Escena - attaches to the skin and delivers the medicine beneath the surface instead of through intravenous infusion.
The agency's decision provides patients receiving treatment for multiple myeloma, a rare blood cancer originating in the bone marrow when plasma cells become cancerous and multiply uncontrollably, with an alternative to longer infusion visits. Subcutaneous dosing can markedly reduce the time patients spend in infusion centers when treatments are given repeatedly, and it can also lessen workload pressures on oncology clinics and nursing staff.
Sanofi first secured U.S. approval for an intravenous version of Sarclisa in 2020 for patients previously treated for relapsed multiple myeloma. The new approval expands the drug’s administration options by permitting use of the wearable injector, which is intended to be attached to the patient’s skin for dosing.
The regulatory nod arrives as Sanofi navigates leadership and pipeline changes. The approval is being framed as a regulatory win as new Chief Executive Belén Garijo seeks to strengthen the company’s development portfolio and reduce investor concerns about heavy reliance on Dupixent, Sanofi’s top-selling asthma medicine. Separately, the company last month appointed Paulo Fontoura as its new head of research and development.
From a care-delivery standpoint, subcutaneous administration through a wearable on-body injector is positioned to improve convenience for patients who require repeated treatment courses and to relieve some of the operational strain experienced by infusion centers and oncology nursing teams. The specific commercial and uptake details for the wearable formulation were not provided in the announcement.
Overall, the FDA approval of Sarclisa Escena gives Sanofi an additional approved option for treating multiple myeloma patients and a tangible example of product innovation in delivery format that can affect patient time in clinics and clinic resource use.