The U.S. Food and Drug Administration (FDA) has postponed its decision on Eli Lilly’s oral obesity medication orforglipron, along with three other drugs that previously received the Commissioner’s National Priority Voucher, according to a report from Reuters.
Reuters cited internal regulatory documents indicating that the new target action date for orforglipron is April 10, 2026. The original decision was expected by March 28, as agency leaders aimed to accelerate the review ahead of the initial May 20 deadline.
Sanofi’s type 1 diabetes treatment Tzield also faces a delayed timeline after the FDA observed safety concerns, including two seizures, an episode of blood clotting, and one death. Disc Medicine’s bitopertin—intended for treating porphyria—has been delayed due to questions about its efficacy data and potential abuse risk. The review period for Tzield will be extended by more than a month, while bitopertin will see a two-week delay.
Additionally, Boehringer Ingelheim’s kinase inhibitor zongertinib, proposed for non-small cell lung cancer treatment, is now expected to receive an FDA decision in mid-February. The original action date for this drug was not specified.
BioSpace has contacted all companies involved for comment.
All four therapies were recipients of the FDA’s Commissioner’s National Priority Vouchers last year. This program began in June 2025 with the goal of reducing regulatory review times from up to a year down to as little as one or two months. To qualify for these vouchers, companies had to commit to government-set priorities such as addressing unmet medical needs, increasing domestic manufacturing capacity, and lowering drug prices under President Donald Trump’s Most Favored Nation policy.
The first round of vouchers was distributed in October last year and included Tzield and bitopertin. Lilly and Boehringer received their vouchers during a second award cycle in November. The FDA later granted Johnson & Johnson a voucher proactively without an application from the company.
