Sanofi makes no mention of the Commissioner’s National Priority Voucher. Tzield was awarded the ticket in October 2025, but Sanofi requested withdrawal from the program after former CDER head Tracy Beth Høeg reportedly expressed skepticism of the drug.
Sanofi’s antibody therapy Tzield has been cleared by the FDA for the treatment of type 1 diabetes in pediatric patients—an approval that comes amid reported internal disagreements about the drug at the agency and the use of a controversial voucher program for accelerating review times.
Tzield’s label expansion, granted Friday under the FDA’s accelerated pathway, extends the drug’s use to patients ages eight through 17 years who have recently been diagnosed with stage 3 type 1 diabetes, delaying the decline in endogenous insulin production in these patients.
Tzield’s continued approval in this setting and indication will depend on the validation of clinical benefit in a confirmatory study. Sanofi has launched the Phase 3 BETA-PRESERVE trial to fulfill this requirement. The trial is currently recruiting participants and is expected to readout in 2028.
Data from the Phase 3 PROTECT trial supported the FDA’s approval on Friday, Sanofi said. The study looked at Tzield’s effect on C-peptide levels—a surrogate endpoint indicative of the pancreas’ capacity of secreting insulin—for adolescents with type 1 diabetes. PROTECT found that Tzield significantly slowed the decline of mean C-peptide concentrations versus placebo, as measured by a mixed-meal tolerance test.
In October last year, the PROTECT study paved the path for another regulatory reward for Tzield: the Commissioner’s National Priority Voucher (CNPV), a ticket that the FDA grants to companies who align with certain national priorities, like addressing unmet medical needs, lowering prices or boosting domestic supply chains.
When used, CNPVs can drastically shave review times for drug applications down to 1–2 months, compared to the typical 10–12 months.
“This is a recognition of the breakthrough innovative profile of Tzield,” Olivier Charmeil, executive vice president of general medicines at Sanofi, said in a prepared statement at the time of the CNPV award. Nearly half a year later, however, the pharma reportedly wanted out of the CNPV program after some internal disagreements at the FDA over the verdict on Tzield’s approval.
Reviewers at the agency supposedly were in favor of expanding the drug’s label to include children eight years and up with stage 3 type 1 diabetes, according to reporting by STAT News in May. But Tracy Beth Høeg, former acting director of the Center for Drug Evaluation and Research, reportedly disagreed and argued that Tzield’s benefits in this population did not outweigh its risks.
It isn’t clear what became of Sanofi’s request to withdraw Tzield from the CNPV program, but Høeg is no longer at the agency after being fired that same month. She has been succeeded by CDER deputy director Michael Davis, who leads the center on an acting basis until a permanent replacement is named.
Sanofi made no mention of the CNPV in its news release of Tzield’s approval on Friday.
