Sanofi’s antibody therapy Tzield was cleared by the U.S. Food and Drug Administration for the treatment of type 1 diabetes in pediatric patients, according to a June 15 announcement. The approval extends Tzield’s use to patients ages eight through 17 years who have recently been diagnosed with stage 3 type 1 diabetes, allowing the drug to delay the decline in endogenous insulin production.
The FDA granted this label expansion under its accelerated pathway. Continued approval will depend on validation of clinical benefit through a confirmatory study. Sanofi has launched the Phase 3 BETA-PRESERVE trial to meet this requirement; it is currently recruiting participants and is expected to read out in 2028.
Data from the Phase 3 PROTECT trial supported Friday's FDA decision, Sanofi said. The study evaluated Tzield’s effect on C-peptide levels—a surrogate marker for pancreatic insulin secretion—in adolescents with type 1 diabetes. According to Sanofi, PROTECT found that Tzield significantly slowed the decline of mean C-peptide concentrations compared with placebo, as measured by a mixed-meal tolerance test.
In October last year, results from PROTECT led to another regulatory milestone: awarding of the Commissioner’s National Priority Voucher (CNPV) for Tzield, which can accelerate review times for drug applications from around ten months down to one or two months if used. At that time, Olivier Charmeil, executive vice president of general medicines at Sanofi, said in a prepared statement, “This is a recognition of the breakthrough innovative profile of Tzield.”
However, nearly half a year later Sanofi reportedly sought removal from the CNPV program following internal disagreements at the FDA regarding Tzield's approval verdict. Reviewers were reportedly supportive of expanding use, but Tracy Beth Høeg—then acting director of the Center for Drug Evaluation and Research—disagreed over whether benefits outweighed risks in this population. Høeg was subsequently fired and replaced on an acting basis by deputy director Michael Davis.
Sanofi did not mention CNPV status in its news release about Friday's approval.
