Sanofi MS Drug Hits Two Setbacks

Sanofi MS drug hits two setbacks

Tolebrutinib, which Sanofi acquired in a $3.7 billion buyout, failed a Phase 3 study in “primary progressive” multiple sclerosis and is facing a delayed U.S. approval decision in another form of the disease.

Sanofi facing tolebrutinib setback in MS - European Biotechnology Magazine

Sanofi’s tolebrutinib fails Phase III in PPMS, while FDA postpones decision on targeted therapy approval for nrSPMS. Sanofi’s tolebrutinib fails Phase 3 in PPMS; FDA nrSPMS decision delayed. Highlights challenges and BTK inhibitor landscape in progressive MS.

Sanofi’s multiple sclerosis drug flunks Phase 3 trial, faces another PDUFA delay

Sanofi reported that its BTK inhibitor which it said has blockbuster potential in multiple sclerosis hit setbacks in two different forms of the disease. The French drugmaker said tolebrutinib failed a ...