The EMA’s CHMP recommended approval of Sanofi’s Cenrifki (tolebrutinib) for non-relapsing secondary progressive multiple sclerosis. The phase 3 HERCULES study showed reduced disability progression, while liver injury remains an identified safety risk.
A Phase 1 trial of azer-cel, a CAR T-cell therapy using donor T-cells to target B-cells, is recruiting patients with progressive multiple sclerosis at eight U.S. sites. Separately, multiple randomized trials are comparing hematopoietic stem cell transplantation against high-efficacy disease-modifying therapies.
Phase III FENtrepid trial results show investigational BTK inhibitor fenebrutinib met its primary endpoint of non-inferiority to ocrelizumab in primary progressive MS, with a 12% reduction in disability progression risk and strongest effect on upper limb function.
