FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib

Sanofi (SNY) announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation independent of relapse activity in adults. The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected by Sept. 28, 2025.The FDA filing is supported by data from three late-stage studies — one ( ...