The Prescription Medicines Code of Practice Authority (PMCPA), the UK pharmaceutical industry’s self-regulatory body, has ruled that Sanofi breached the UK Code of Practice by making unsubstantiated comparative claims regarding its infant respiratory syncytial virus (RSV) product Beyfortus. In response to a complaint lodged by Pfizer, the PMCPA found that Sanofi’s promotional materials asserted Beyfortus was more effective and conferred superior duration of protection compared to Pfizer’s RSV vaccine without robust head-to-head clinical trial data. The ruling highlights that Sanofi failed to provide adequate evidence for these comparative statements, contravening Sections 7.2 and 7.3 of the code. The PMCPA has instructed Sanofi to withdraw the offending materials and issue corrective communications to healthcare professionals within 28 days, a process that may incur additional legal and compliance costs and could impact market perception in the competitive RSV prevention space.

Sanofi reported topline results from the LEAP2MONO Phase 3 study of oral venglustat in type 3 Gaucher disease (GD3), a condition characterized by neurological and visceral symptoms. Of 43 patients randomized, venglustat met the primary endpoint—reduction in central nervous system substrate accumulation—and achieved three of four key secondary endpoints, including comparable reductions in spleen volume, liver volume and maintenance of hemoglobin levels versus bi-weekly enzyme replacement therapy (ERT). Safety was consistent with prior studies, with no new signals observed. Despite mixed results in the PERIDOT trial for Fabry disease—where both vzd and control arms showed pain reduction and the primary endpoint wasn’t met—Sanofi confirmed plans to file global regulatory submissions for GD3 later this year. A second Fabry study, CARAT, assessing cardiac ventricular mass index in both sexes is ongoing. Investors will note that successful approval could expand Sanofi’s lysosomal storage disorder portfolio alongside existing products Fabrazyme, Cerezyme and Cerdelga, while the outcome of additional analyses and open-label data from LEAP2MONO will be critical for long-term revenue projections.