Notable Quotes
We are very disappointed by the FDA's action. Disability progression remains a large unmet medical need in MS, and tolebrutinib was awarded breakthrough therapy designation in recognition of its potential to address this critical gap.
Today's FDA decision is a significant and meaningful change in direction from the feedback the agency previously provided to Sanofi. We are very disappointed by the FDA's action. Disability progression remains a large unmet medical need in MS, and tolebrutinib was awarded breakthrough therapy designation in recognition of its potential to address this critical gap.