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# Sanofi Seeks Removal of Tzield From FDA Priority Review Program
- URL: https://www.fdaweb.com/sanofi-seeks-removal-of-tzield-from-fda-priority-review-program/
- Published: 2026-05-07T12:00:00.000Z
- Updated: 2026-09-14T13:38:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161110

Sanofi has reportedly asked FDA to remove its Type 1 diabetes therapy Tzield from the agency’s National Priority Voucher review program following an internal disagreement over the drug’s supplemental application, according to multiple media reports.

The dispute centers on a proposed label expansion for Tzield to treat adults and children aged eight and older with stage 3 Type 1 diabetes. [*STAT News*](https://www.statnews.com/2026/05/06/sanofi-asks-to-pull-diabetes-drug-teplizumab-makary-fda-voucher-program/?ref=fdaweb.com) reported Wednesday that FDA review staff supported approval of the application, but acting CDER director **Tracy Beth Hoeg** raised concerns that the therapy’s benefits may not outweigh its risks.

Tzield is currently approved to delay the onset of stage 3 Type 1 diabetes in certain patients with stage 2 disease and recently gained an expanded pediatric indication for children as young as one year old.

The application had been placed into FDA’s voucher program, an initiative launched last year to accelerate review timelines for products deemed national priorities. Sanofi reportedly had expected an FDA decision by 4/21, though the agency delayed action earlier this year after identifying safety concerns.

According to earlier reporting by Reuters, FDA cited adverse events including seizures, a blood-clotting event and a death. STAT later reported that Hoeg’s concerns also involved Epstein-Barr virus reactivation and potential cancer risk. Tzield’s prescribing information already includes warnings about serious viral reactivation involving Epstein-Barr virus and cytomegalovirus.

Sanofi has declined to comment on confidential discussions with FDA but confirmed that the supplemental BLA remains under review. The company defended the therapy’s safety profile, noting that more than 1,000 patients have received teplizumab during three decades of clinical development.

Sanofi said three malignancy cases had been observed during development but that “no causal relationship was established” between the cancers and the drug. The company also said no causal link had been established between Tzield and the reported fatality.

The reports add to growing scrutiny over the role of senior FDA leadership in regulatory decisions under commissioner **Marty Makary**. During a CNBC interview this week ([see story](https://www.fdaweb.com/makary-defends-fda-drug-decisions/)), Makary said all approval and rejection decisions during his tenure reflected recommendations made by primary FDA review teams.

According to *STAT*, Hoeg has called for an advisory committee meeting on the Tzield application after realizing she would need to override FDA review staff.