Sanofi: U.S. FDA Extends Review Period for BTK Inhibitor Tolebrutinib New Drug Application

Sanofi announced on September 22 that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of the BTK inhibitor Tolebrutinib by three months. Based on additional analysis data submitted during the review period, the FDA determined that the new information constitutes a major amendment to the NDA, accordingly extending the target action date. The revised FDA decision target date is December 28, 2025. Sanofi stated it remains confident in the potential positive efficacy of this product.