EMA’s CHMP backs Sanofi BTK inhibitor rebuffed by FDA

At its April meeting, EMA’s CHMP recommended approval of Sanofi’s BTK inhibitor Cenrifki for secondary progressive multiple sclerosis, diverging from FDA’s December complete response letter. CHMP aligned with FDA, however, on Arrowhead’s APOC3-targeting siRNA Redemplo for familial chylomicronemia syndrome, issuing a positive opinion that could make the therapy Europe’s first for FCS.

CHMP’s positive opinion for Cenrifki tolebrutinib from Sanofi (Euronext:SAN; NASDAQ:SNY) was based on the 1,131-patient Phase III HERCULES study, supported by data from GEMINI 1 and GEMINI 2 in relapsing MS. CHMP concluded that Cenrifki’s benefits included a 31% reduction in the risk of six-month confirmed disability progression and a 38% reduction in the adjusted mean number of new or enlarging T2-hyperintense lesions per year versus placebo...