The FDA delayed reviews of two drugs selected for its National Priority Voucher Program due to safety and efficacy concerns, according to internal documents reported in an exclusive Jan. 15 report by Reuters.
Sanofi’s bid to expand Tzield for late-stage Type 1 diabetes was delayed more than a month after the FDA flagged serious adverse events, including seizures, blood clotting and a treatment-related death.
In a statement shared with Becker’s, a Sanofi spokesperson said the patient death remains under assessment and “no causal relationship to Tzield has been established at this time.” The company added that blood clotting and seizures “have no known causal association to Tzield based on our thorough assessment of our safety database.”
Sanofi said it is collaborating with the FDA to support a thorough and transparent review and maintains a “robust pharmacovigilance system” to evaluate and report adverse events. The company said it continues to provide requested information to the FDA and remains confident in Tzield’s benefit-risk profile.
The FDA also extended its review of Disc Medicine’s bitopertin for a rare blood disorder to Feb. 10 amid questions about trial endpoints and potential abuse risk.
The fast-track program, launched in June by the Trump administration, promised one- to two-month reviews for select drugs critical to public health, U.S. manufacturing or affordability. But four of the first seven drugs in the program have already missed initial decision timelines.
Andrew Nixon, a spokesperson for HHS, told Reuters the FDA retains discretion to adjust timelines based on internal evaluations. In a separate statement to Becker’s, the agency said information about potential or pending drug applications “is confidential unless it has been publicly disclosed by the sponsor.” Disc leaders said the company remains confident in bitopertin’s safety profile and clinical benefit, though final approval is up to the agency.
Only one drug — Augmentin XR, an oral antibiotic — has been approved under the voucher initiative to date.
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