Sanofi announced FDA’s acceptance of Tzeild’s supplemental biologics license application (sBLA) for expedited review under the Commissioner's National Priority Voucher pilot program.

The drug is included in the agency’s program based on its potential to address a large unmet medical need. The program was designed to reduce the review process from its standard 10-12 month review process to 1-2 months, while maintaining FDA's rigorous safety and efficacy standards.¹

"We welcome that Tzield has been accepted for expedited review by the FDA under the Commissioner’s National Priority Voucher pilot program, potentially enabling us to go further and faster for patients and lead the way with breakthrough science," said Olivier Charmeil, executive vice president of general medicines at Sanofi. "This is a recognition of the breakthrough innovative profile of Tzield, its ability to potentially prevent the natural progression of T1D, and the significant unmet medical need that remains in this area which has seen limited treatment advances in the last 100 years.”

Why was Tzield accepted into The Commissioner’s National Priority Voucher Program?

Sanofi submitted Tzeild’s sBLA for review with supporting results collected from the PROTECT phase III study, which met its primary endpoint evaluating preservation of beta cell function as assessed by significantly slowing the decrease in mean C-peptide levels at trial study completion, compared to placebo.¹ The sBLA builds on the clinical development program of Tzield, which includes over 1,000 actively participating patients.¹ Additionally, adverse events recorded in the PROTECT phase III study were consistent with previous studies, which included headache, nausea, rash, lymphopenia, leukopenia and gastrointestinal symptoms, consistent with the mode of action of cytokine release.¹ 

Tzield is currently approved in the US, UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait, as a delay for the onset of stage 3 T1D in adults and pediatric patients eight years and older diagnosed with stage 2 T1D.¹ The treatment is still currently undergoing regulatory reviews in the EU and in other medical programs around the world. Tzield was previously designated by the FDA as Breakthrough Therapy and was granted orphan drug designation for investigational medicines that treat rare diseases affecting fewer than 200,000 people in the US.

What is The Commissioner’s National Priority Voucher Program?

The Commissioner’s National Priority Voucher Program was originally revealed back in June of this year and is a new initiative for FDA to promote novel treatments that the agency believes will benefit the health interests of Americans. This includes medications that meet a large, unmet need or reduce downstream health care utilization. Medications that will also utilize MFN pricing may also be considered for the program. Drugs that are accepted to be part of the program are expected to receive a decision from the agency within 1-2 month once a complete application has been filed. Sponsors will also be granted enhanced communication with FDA, who reserves the right to extend the review time should it find it necessary to do so.

Tzield is one of the first nine medications to be accepted into the program, with the other eight including, Pergoveris for infertility, Cytisinicline for nicotine vaping addiction, DB-OTO for deafness, Cenegermin-bkbj for blindness, RMC-6236 for pancreatic cancer, Bitopertin for porphyria, Ketamine for domestic manufacturing of a critical drug for general anesthesia, and Augmentin XR for domestic manufacturing of a common antibiotic.

Sources

1. Press Release: Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program Sanofi October 20, 2025 https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-20-11-30-00-3169262
2. FDA Awards First-Ever National Priority Vouchers to Nine Sponsors. FDA. October 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors