Sanofi SA (NASDAQ:SNY) secured two regulatory milestones this week, with European authorities approving Cenrifki for non-relapsing secondary progressive multiple sclerosis (nrSPMS) and Japanese regulators authorizing Wayrilz for persistent and chronic immune thrombocytopenia.
Read Also: Sanofi Trial Setback May Reinforce Argenx Vyvgart's Position In CIDP, Analyst Says European Commission Clears Cenrifki For Non-Relapsing SPMS The European Commission approved Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis (SPMS) who have not experienced relapses during the previous two years.
The approval was supported primarily by findings from the Phase 3 HERCULES study in non-relapsing SPMS, along with data from the Phase 3 GEMINI 1 and GEMINI 2 studies in relapsing multiple sclerosis.
Results from HERCULES showed that Cenrifki significantly delayed disability progression in patients with non-relapsing SPMS, an area with limited treatment options.
Investigators also observed significant liver enzyme elevations, with drug-induced liver injury identified as a known safety risk.
