French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Friday that the Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM).

The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).

A regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is currently under review in Japan. If approved, Sanofi says that Sarclisa SC could become the first anticancer treatment to be administered via an OBI, and the first MM medicine in Japan to offer both manual SC injection and OBI administration.

The approval is based on results from the IRAKLIA phase 3 study in R/R MM, which demonstrated non-inferiority of the SC formulation compared to IV, as well as supportive studies. In addition to manual SC injection, these studies evaluated Sarclisa SC administered through an OBI, and were conducted using Enable Injections' enFuse hands-free OBI.