The Prescription Medicines Code of Practice Authority (PMCPA) has ruled that Sanofi violated the UK Code of Practice by making unsubstantiated claims that its monoclonal antibody Beyfortus provided superior protection against respiratory syncytial virus (RSV) compared with Pfizer’s RSV vaccine. The decision follows a formal complaint lodged by a competitor, and the regulator noted that Sanofi’s promotional materials lacked adequate clinical data to support comparative efficacy statements. Sanofi must now issue a corrective communication to all recipients of the original materials and submit a compliance plan to the PMCPA within 28 days. This ruling could delay Sanofi’s promotional efforts for Beyfortus in the UK market and exposes the company to potential reputational risks among healthcare professionals.

Sanofi reported topline results from the LEAP2MONO Phase 3 trial of oral venglustat versus biweekly enzyme replacement therapy (ERT) in 43 patients aged 12 and older with type 3 Gaucher disease (GD3). The glucosylceramide synthase inhibitor met its primary endpoint—significant reduction in cerebrospinal fluid glucosylceramide levels—and achieved three of four key secondary endpoints, including stabilized spleen volume, liver volume and hemoglobin levels. Venglustat’s safety profile was consistent with previous studies, with no new adverse signals identified. Conversely, the PERIDOT Phase 3 trial in Fabry disease failed to meet its primary endpoint of neuropathic and abdominal pain reduction, although both arms saw symptom improvement. Sanofi plans to submit regulatory applications in major markets for GD3 by mid-2026 and will present open-label LEAP2MONO data later this year, while continuing the ongoing CARAT cardiovascular study in Fabry patients.