Sanofi announced that the European Commission has granted marketing authorization for Teizeild (teplizumab), a CD3‑directed monoclonal antibody that delays the progression from stage 2 to stage 3 type 1 diabetes in patients eight years of age and older. The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and marks the first disease‑modifying therapy for type 1 diabetes approved in the EU.
Teizeild’s clinical profile is anchored in the pivotal TN‑10 Phase 2 study, which enrolled 76 children and adults with stage 2 disease. Participants received a single 14‑day course of Teizeild, and the trial demonstrated a median delay to stage 3 of 49.5 months versus 24.9 months for placebo, with 57 % of treated patients remaining in stage 2 compared to 28 % of placebo patients. The drug’s mechanism—engaging CD3 on T‑cells to preserve beta‑cell function—offers a preventive strategy rather than a treatment for established disease.
The approval expands Sanofi’s immunology portfolio into a new therapeutic area and provides a potential new revenue stream. Analysts note that the drug’s entry into the EU market, where it had already been approved in the United States, United Kingdom, China, Canada, Israel, Saudi Arabia, the UAE, and Kuwait, positions Sanofi to capture a growing unmet need. The company’s decision not to pursue a second application for stage 3 disease at this time reflects a strategic focus on the approved indication and a desire to allocate resources to scaling access and commercialization.
Olivier Charmeil, Executive Vice President for General Medicines, said the approval “demonstrates Sanofi’s commitment to delivering disease‑modifying therapies that can change the trajectory of type 1 diabetes.” He added that the company will work with external stakeholders across the EU to bring patients the benefits of Teizeild, emphasizing the company’s patient‑centric approach and its broader strategy to strengthen its position in the immunology space.
Sanofi’s recent financial performance underscores the significance of the approval. In the first quarter of 2025, the company reported sales up 9.7 % at constant exchange rates and a business earnings per share of €1.79, confirming its 2025 guidance for mid‑to‑high single‑digit sales growth and low double‑digit business EPS growth. The new EU approval is expected to support the company’s long‑term growth trajectory and enhance its competitive standing against other immunology players.
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