The U.S. Food and Drug Administration has delayed regulatory decisions for four drugs that were selected for accelerated review under the Commissioner’s National Priority Voucher program, according to internal documents reviewed by Reuters. The affected drugs are sponsored by Eli Lilly, Sanofi, Boehringer Ingelheim, and Disc Medicine.
The FDA has extended its review period for Eli Lilly’s oral obesity drug orforglipron. Reuters reported that the drug’s new target action date is April 10, 2026. An earlier Reuters report had identified March 28 as the anticipated decision date, following efforts to complete the review ahead of the original May 20 deadline. A Lilly spokesperson confirmed that approval could now occur in the second quarter, based on current FDA guidance.
Sanofi’s type 1 diabetes therapy Tzield has also experienced a delay, extending its review by more than a month. According to internal documents cited by Reuters, FDA reviewers flagged safety concerns, including two seizures, one blood-clotting event, and one reported death.
The agency asked Sanofi to provide additional information on several serious adverse events it considered possibly related to the drug. Sanofi stated that it rigorously evaluates all serious adverse event reports and continues to work closely with the FDA on the application to expand Tzield’s use.
Disc Medicine’s experimental drug bitopertin, which is being developed to treat a rare blood disorder that causes extreme sensitivity to sunlight, has had its accelerated review extended by approximately two weeks. The FDA moved the target action date to February 10. Regulators questioned whether pain-free time spent in the sun, a secondary endpoint used in clinical trials, was a statistically reliable measure of effectiveness. FDA staff were also reviewing whether the drug posed any potential for abuse, according to internal documents.
The FDA has also extended its review of Boehringer Ingelheim’s kinase inhibitor zongertinib, which is being proposed as a treatment for non-small cell lung cancer. Reuters reported that a decision is now expected in mid-February, although the original target date was not disclosed. A Boehringer spokesperson said a decision is expected in the near future.
All four drugs were awarded Commissioner’s National Priority Vouchers last year. The program, launched in June 2025, aimed to reduce regulatory review timelines from the standard 10 to 12 months to one or two months. Vouchers are awarded to companies that commit to government priorities, including addressing unmet medical needs, increasing domestic manufacturing, or offering lower drug prices under the administration’s policy framework.
The FDA distributed its first vouchers in October, including those awarded to Sanofi and Disc Medicine. Eli Lilly and Boehringer Ingelheim received their vouchers during the second award cycle in November. According to internal documents, at least seven drugs in the program have begun the approval process, while 18 medicines in total are expected to receive expedited reviews. Only one drug, a generic antibiotic, has been approved under the program so far.
Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, said, “It is a very good sign the FDA in this program is willing to say: ‘Hold on, we’re not actually sure this product should be allowed on the market.”
FDA Pushes Back Review Decisions for Four Drugs in National Priority Voucher Program
The U.S. Food and Drug Administration (FDA) has announced that review timelines for Four Drugs under the National Priority Review Voucher (PRV) Program will be delayed, impacting expected approval dates. The PRV Program is designed to expedite development and review of treatments for rare diseases, tropical diseases, and other high-priority conditions. Delays in the review of Four Drugs highlight the complexities regulators face in balancing speed with rigorous safety and efficacy evaluations. (fda.gov)
The Four Drugs affected were scheduled for priority review due to their potential to address serious unmet medical needs. While the FDA continues to work on these submissions, sponsors and patients may experience adjustments in expected timelines. These decisions emphasize the importance of careful regulatory oversight, even under programs intended to accelerate approvals. (fiercepharma.com)
