The country’s Ministry of Health, Labour and Welfare approved Sanofi’s push-button CirCLIQ Injector for administering a subcutaneous formulation of Sarclisa (isatuximab-irfc), a monoclonal antibody for multiple myeloma used in combination with standard-of-care regimens.
According to Enable, the CirCLIQ approval also marks the first in Japan for an anticancer treatment delivered by an on-body injector. The therapy has collected similar firsts this year in the U.S. and Europe — passing the FDA’s muster in July, with the drug marketed as Sarclisa Escena, shortly after receiving a European Union approval in June.
“This approval is another important milestone in our mission to expand access to novel drug delivery solutions around the world,” Enable CEO Michael Hooven said in a statement. “As the adoption of subcutaneous delivery continues to grow globally, we’re excited to help our pharmaceutical partners bring more therapies to patients.”
The enFuse device uses a short and thin retractable needle for large-volume boluses. The Cincinnati-based Enable says it is working with drugmakers in R&D and clinical trials for future launches across oncology, hematology, immunology and rare diseases.
Related: Enable Injections to expand manufacturing facility to support drug delivery device production
Sarclisa, including intravenous doses, has been approved for years in nearly 60 countries. In Japan, Sarclisa SC and CirCLIQ were approved in combination with carfilzomib or pomalidomide and dexamethasone in relapsed or refractory multiple myeloma, and for use with bortezomib, lenalidomide and dexamethasone for newly diagnosed cases.
Sanofi previously invested $30 million in Enable at the top of this year to help bolster its manufacturing capacity. Enable’s on-body tech previously acquired an FDA approval in 2023 with Apellis Pharmaceuticals’ Empaveli for paroxysmal nocturnal hemoglobinuria.
