Sanofi today announced the appointment of Paulo Fontoura, MD, PhD, FAAN, as Executive Vice President, Global Head of Research & Development Pharma, effective September 1, 2026. Based in Paris, Fontoura will join Sanofi's Executive Committee and report to Chief Executive Officer Belén Garijo. He succeeds Dr. Houman Ashrafian, who is leaving the company to pursue an external opportunity.

In his new role, Fontoura will lead Sanofi's end-to-end innovation engine, encompassing research, translational medicine, clinical development, and regulatory affairs. His primary responsibility will be advancing a differentiated pipeline and accelerating the delivery of transformative medicines to patients. The appointment comes as Sanofi continues its R&D transformation and progresses a pipeline of new medicines across multiple therapeutic areas.

Fontoura brings more than 25 years of experience in academic medicine, translational science, clinical development, and pharmaceutical innovation. Most recently, he served as Chief Medical Officer of Xaira Therapeutics, an AI-native biotechnology company. Prior to that, he spent over 15 years at Roche, where he held senior leadership positions, including Senior Vice President and Global Head of Clinical Development for Neuroscience, Immunology, Ophthalmology, Infectious and Rare Diseases.

Paulo Fontoura's Profile

During his tenure at Roche, Fontoura oversaw a global organization of physicians and clinical scientists and managed a broad late-stage portfolio. His teams contributed to the development of over 60 new molecular entities, leading to over 20 FDA and EMA first approvals and line extensions. He is a board-certified neurologist and a Fellow of the American Academy of Neurology, having authored more than 80 peer-reviewed scientific publications.

Belén Garijo, Chief Executive Officer of Sanofi, expressed confidence in the new appointment, highlighting Fontoura's respected leadership and strong track record across research, development, and innovation. Fontoura stated he is thrilled to join Sanofi at an exciting moment, citing the company's leadership position in immunology and its commitment to scientific innovation and AI-powered transformation.

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.