The U.S. Food and Drug Administration has pushed back its decision on Sanofi’s anti-diabetic biologic Tzield by more than one month, citing new data on seizure events and a treatment-related death observed in ongoing trials. Tzield, developed for patients with type 1 diabetes to reduce hypoglycaemic episodes and insulin requirements, was originally slated for a late-March decision. The agency’s request for additional safety analyses and longer follow-up will extend the review into mid-May. Regulatory consultants note that these supplementary data requirements signal heightened caution at the agency and could set a precedent for more rigorous scrutiny of large-molecule therapies in the coming year.

On January 15, China’s National Medical Products Administration granted marketing authorisation to Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy and to Redemplo (plozasiran) for familial chylomicronemia syndrome (FCS). The approvals mark Sanofi’s second and third late-stage product launches in Greater China since mid-2025. Myqorzo’s approval followed positive results from the SEQUOIA-HCM phase III trial, which demonstrated a 20% increase in peak oxygen uptake and a 35% reduction in left-ventricular outflow tract gradient. Redemplo’s PALISADE study showed a median 85% reduction in triglyceride levels from baseline at six months. Analysts estimate these two franchises could contribute more than €400 million in annual revenues by 2028, bolstering Sanofi’s position in high-growth specialty markets.