UK Industry Body Finds Sanofi Breached Code Over Beyfortus Claims, Phase 3 Venglustat Hits 4 Endpoints
UK pharma regulator found Sanofi in breach over unsubstantiated claims that Beyfortus outperformed Pfizer’s RSV vaccine, risking reputational and regulatory penalties. In its pipeline, phase 3 venglustat met the primary endpoint and three of four key secondary endpoints in type 3 Gaucher disease, prompting planned global filings despite Fabry trial failure.
1. UK Pharma Code Ruling Against Sanofi Over RSV Therapy Claims
The Prescription Medicines Code of Practice Authority (PMCPA), the UK industry’s self-regulatory body, has determined that Sanofi breached the British Pharmaceutical Industry 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 ruling follows a formal complaint by a competing manufacturer, which cited promotional materials and public statements from Sanofi’s UK affiliate. The PMCPA found that Sanofi failed to provide robust clinical data in support of comparative effectiveness, noting that no head-to-head trial between Beyfortus and Pfizer’s vaccine exists and that extrapolations from separate trials did not meet the standard for promotional claims. As a consequence, Sanofi UK must withdraw or correct all references to Beyfortus’ alleged superiority and submit a remedial plan to ensure future compliance, potentially damaging the therapy’s market positioning ahead of the upcoming winter respiratory season.
2. Sanofi Advances Venglustat Regulatory Strategy After Mixed Phase 3 Results
In the LEAP2MONO phase 3 trial for type 3 Gaucher disease (GD3), Sanofi reported that once-daily oral venglustat met the primary composite endpoint and three of four key secondary endpoints versus biweekly intravenous enzyme replacement therapy (ERT) in 43 patients aged 12 and older with neurological manifestations. Venglustat demonstrated comparable reductions in spleen volume (–28%), liver volume (–17%) and improvements in hemoglobin concentration (mean increase 1.2 g/dL) at 12 months, matching ERT performance on non-neurological measures. Sanofi intends to file for regulatory approval in major markets based on these results, highlighting the drug’s ability to cross the blood-brain barrier. However, data from the PERIDOT phase 3 study in Fabry disease did not meet its primary endpoint of pain reduction, though both treatment arms recorded similar decreases in neuropathic and abdominal pain. A separate phase 3 CARAT study evaluating cardiac outcomes in Fabry disease is ongoing. Sanofi noted that venglustat was well tolerated with no new safety signals and plans to present open-label extension results later this year.