Sanofi: FDA extends review period for new drug application for Tolebrutinib, a BTK inhibitor.

Sanofi announced on September 22 that the U.S. Food and Drug Administration has extended the review date for the new drug application for the BTK inhibitor Tolebrutinib by three months. Based on supplemental analysis data submitted during the review period, the FDA has determined that the additional information constitutes a significant revision to the NDA, thus extending the target action date accordingly. The revised FDA decision target date is December 28, 2025. Sanofi expressed confidence in the potential positive effects of this product.