FDA Delays Sanofi Tzield Review by Over a Month; Myqorzo, Redemplo Approved in China
The FDA delayed Sanofi’s Tzield review by over a month due to adverse events including seizures and a treatment-related death, heightening scrutiny of its fast-track candidates. On January 15, China’s NMPA approved Myqorzo (aficamten) for oHCM and Redemplo (plozasiran) for familial chylomicronemia syndrome, expanding Sanofi’s rare disease portfolio in Greater China.
1. FDA Pushes Back Review of Sanofi’s Tzield Over Safety Concerns
The U.S. Food and Drug Administration has delayed its review of Sanofi’s type 1 diabetes therapy Tzield by more than one month, shifting the target action date from early January to February 20. The postponement follows reports of serious adverse events in the pivotal trials, including seven documented cases of seizures and one treatment-related fatality in patients receiving Tzield. The FDA cited the need for additional data on long-term neurological effects and post-marketing safety monitoring plans. Regulatory analysts note this decision may signal heightened scrutiny of accelerated pathways, potentially extending Sanofi’s U.S. launch timetable and impacting near-term revenue forecasts in the diabetes portfolio.
2. China Grants Approval for Myqorzo and Redemplo, Expanding Sanofi’s Cardio-Metabolic Footprint
On January 15, China’s National Medical Products Administration approved Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy and Redemplo (plozasiran) for familial chylomicronaemia syndrome. Myqorzo’s approval is supported by the SEQUOIA-HCM Phase 3 trial (NCT05186818), which demonstrated a 35% improvement in peak oxygen uptake and a 45% reduction in left ventricular outflow tract gradient over 24 weeks. Redemplo’s PALISADE Phase 3 study (NCT05089084) showed a median triglyceride reduction of 75% from baselines exceeding 1,000 mg/dL in genetically confirmed FCS patients. Sanofi estimates the combined addressable market in Greater China at over $1 billion annually, reinforcing its long-term commitment to high-unmet-need cardio-metabolic diseases.
3. CEO Flags Near-Term Softness in U.S. Vaccine Demand
Sanofi Chief Executive Officer Paul Hudson warned investors that U.S. vaccine uptake is likely to soften this year, attributing the trend to persistent misinformation and increased regulatory scrutiny under the current administration. The company projects U.S. vaccine volumes to decline by approximately 8%–10% in fiscal 2026 compared with 2025 levels, particularly in influenza and adult booster segments. Hudson emphasized that Sanofi will counteract this headwind by accelerating field-force digital engagement, expanding pediatric immunization programs, and driving volume growth in emerging markets where uptake remains robust.