French pharmaceutical giant Sanofi has reportedly requested to remove its application for the expanded use of the diabetes drug Tzield from the FDA’s Commissioner’s National Priority Voucher (CNPV) program. This move comes as the CNPV program faces intense scrutiny over transparency and potential political influence.
Background on the CNPV Program Established nearly a year ago, the CNPV program aims to accelerate the review process for products aligned with “national interests,” shortening the timeline from the standard 10–12 months to just 1–2 months. However, the program has been criticized as a potential tool for government officials to reward political allies within the biopharma industry.
Reasons for Sanofi’s withdrawal request According to a report from Stat, Sanofi’s request followed a decision by Dr. Tracy Beth Høeg, Director of the FDA’s Center for Drug Evaluation and Research (CDER), to overturn a staff recommendation for approval.
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The Indication in Question: The withdrawn application concerned Tzield’s potential use in children aged 8 and older with stage 3 Type 1 diabetes (the clinical diagnosis stage) to slow disease progression.
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Safety Concerns: In January, the FDA delayed its review following reports of two seizures and one fatal blood-clotting event. Sanofi maintains that no causal relationship has been established between the drug and these adverse outcomes.
Tzield’s Market Position Despite the setbacks regarding this specific expansion, Tzield has achieved other regulatory milestones:
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2022: Initially approved to delay the onset of stage 3 Type 1 diabetes in adults and children aged 8 and older at stage 2.
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April 2026: Cleared by the FDA for use in children as young as 1 year old at stage 2.
Sanofi declined to comment directly on confidential discussions with the agency but emphasized its continued confidence in Tzield’s safety and efficacy profile.
Source: https://www.fiercepharma.com/pharma/sanofi-requests-exit-controversial-cnpv-fast-track-program-stat