Communiqué de presse : Sanofi fait le point sur la soumission réglementaire du tolebrutinib dans la sclérose en plaques secondaire progressive non-récurrente

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• Impairment test result will have no impact on net income from activities/earnings per share from activities, and financial guidance for 2025 remains unchanged

  80% confidence

• Sanofi is very disappointed by FDA's action

  80% confidence

• Sanofi remains committed to working with FDA to find a path forward for tolebrutinib and ultimately serve the MS patient community

  80% confidence

• FDA's decision represents a significant and important policy reversal from previous feedback the agency had given to Sanofi

  80% confidence

• Sanofi is a biopharmaceutical company that innovates in R&D and leverages AI at scale to improve people's lives and achieve long-term growth

  80% confidence

• FDA should consider input from scientific experts, clinicians and patients on this matter to ensure all perspectives are considered

  80% confidence

• Disability progression remains a major unmet medical need in multiple sclerosis

  80% confidence