The Ministry of Health, Labour and Welfare in Japan has approved Sanofi ’s Sarclisa (isatuximab) subcutaneous (SC) formulation for the treatment of multiple myeloma (MM). This approval covers the use of Sarclisa SC in combination with standard-of-care regimens for both relapsed or refractory MM and newly diagnosed MM. The regulatory decision aims to ease treatment burden and enhance convenience for patients compared to intravenous administration.

The approved indications include combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for relapsed or refractory MM, and combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed MM. A separate regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is under review in Japan. If approved, Sarclisa SC could become the first anticancer treatment in Japan administered via an OBI.

Approval was based on results from the pivotal IRAKLIA phase 3 study (clinical study identifier: NCT05405166), which evaluated the non-inferiority of Sarclisa SC administered via OBI versus Sarclisa IV. The study included adult patients with relapsed or refractory MM who had received at least one prior line of therapy.

Clinical Trial Results

The IRAKLIA study demonstrated that Sarclisa SC administered via an OBI in combination with Pd resulted in an objective response rate (ORR) of 71.1%, compared to 70.5% with Sarclisa IV-Pd. The statistical analysis established non-inferiority with a risk ratio of 1.008 (95% confidence interval: 0.903-1.126; p=0.0006).

The overall safety profile of Sarclisa SC-Pd was consistent with the established safety profile of Sarclisa IV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced infusion reactions, only 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) that occurred in 0.4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2.

Global Regulatory Status

This approval marks the second global approval for Sarclisa SC, following its approval in the EU in June 2026. In the EU, Sarclisa SC administered via both the CirCLIQ OBI and manual injection was approved for the treatment of MM patients across all currently approved indications for the Sarclisa IV formulation. An application for Sarclisa SC administered via both OBI and manual injection is currently under review in the US.

Olivier Nataf, Global Head of Oncology at Sanofi, stated that the approval represents an important evolution in care delivery, noting the potential for the treatment to become Japan's first anticancer therapy administered via an on-body injector.

The US Food and Drug Administration (FDA) has granted accelerated approval to Sanofi 's Tzield (teplizumab-mzwv) to delay the decline of endogenous insulin production in children ages 8 to 17 recently diagnosed with stage 3 type 1 diabetes (T1D). This approval marks the first disease-modifying therapy for this specific patient population, addressing a critical unmet medical need for approximately 64,000 people diagnosed annually. The therapy is not indicated for non-autoimmune dysglycemic conditions.

The regulatory decision was supported by data from the PROTECT phase 3 study and additional data from the global clinical development program from over 900 patients who received Tzield. The study evaluated beta cell function by measuring the decrease in mean C-peptide levels. The study demonstrated a statistically significant difference in least-squares means of 0.13 pmol/mL (95% confidence interval: 0.09-0.17; p<0.001) at trial completion compared to placebo. Adverse events observed in the study were consistent with previous findings, with common reactions including lymphopenia, vomiting, rash, and leukopenia.

PROTECT Phase 3 Study Details

The PROTECT study was a randomized, double-blind, placebo-controlled, multinational trial involving 328 children and adolescents aged eight to 17. Participants were diagnosed with clinical stage 3 T1D within the preceding six weeks and were randomized in a 2:1 ratio to receive either Tzield or placebo. The regimen consisted of an initial course of 12 daily infusions, followed by a second course of 12 daily infusions after 26 weeks, alongside standard-of-care medicines.

Regulatory Status and Safety

This indication is granted under accelerated approval based on evidence of reduced C-peptide decline, a surrogate endpoint reasonably likely to predict clinical benefit. Consequently, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies. The confirmatory BETA-PRESERVE phase 3 study (NCT07088068) has been initiated and is currently enrolling participants.

Serious adverse events reported with Tzield include cytokine release syndrome and life-threatening cases of viral reactivation, particularly in immunocompromised patients. Prior to this approval, the FDA expanded the indication in April 2026 to delay the onset of stage 3 T1D in adults and children eight years and older with stage 2 T1D to include children aged one year and above. Tzield is also approved in the UK, the EU, China, Australia, Canada, Israel, Saudi Arabia, the UAE, Kuwait, Brazil, and Switzerland to delay the onset of stage 3 T1D in patients with stage 2 T1D.