Sanofi says Nexviazyme meets endpoints in phase 3 infantile-onset Pompe study

  • Sanofi reported positive Phase 3 Baby-COMET results for Nexviazyme in treatment-naïve infants with infantile-onset Pompe disease.
  • Data will be presented on July 8, 2026, at the International Congress on Neuromuscular Diseases in Florence.
  • The study met its main goal on survival without invasive ventilation, supporting a planned US filing for an infantile-onset label expansion.
  • Secondary measures also favored Nexviazyme, pointing to broader clinical benefit without detailing technical performance metrics.
  • Sanofi expects the US submission in the second half of 2026, a step toward expanding use beyond its current US late-onset indication.


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