Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
The FDA has extended its review period for Eli Lilly’s oral obesity drug orforglipron and three other Commissioner’s National Priority Voucher awardees, Reuters reported on Thursday.
The target action date for orforglipron now falls on April 10, 2026, the publication reported, citing internal regulatory documents it was able to review. Reuters had previously named an initial decision date of March 28 for the weight loss pill in an exclusive report published last month, noting that agency leaders wanted to accelerate the drug’s review and release a verdict before the original May 20 deadline.
Aside from orforglipron, the FDA has also pushed back the timeline for Sanofi’s type 1 diabetes therapy Tzield after detecting concerning safety signals, including two seizures, one episode of blood clotting and one death, according to Reuters. Disc Medicine’s bitopertin, being developed for the rare blood disorder porphyria, was also delayed amid questions surrounding its efficacy data and its risk of being abused.
The Tzield delay will extend its review by more than a month, Reuters reported, while bitopertin will have to wait two additional weeks for a verdict.
The FDA has also extended its review for Boehringer Ingelheim’s kinase inhibitor zongertinib, which the company is proposing as a treatment for non-small cell lung cancer. A decision for the drug is now expected in mid-February, according to Reuters, though it’s not clear what the original target action date was.
BioSpace has reached out to the companies involved for comment.
All four drugs were awarded the FDA’s Commissioner’s National Priority Vouchers last year. Launched in June 2025, this priority program sought to drastically shorten regulatory review timelines, from the normal 10–12 months down to 1–2 months. These tickets would be awarded to companies that pledged to comply with certain national priorities set by the government, such as addressing a key unmet need, boosting domestic manufacturing and bringing down drug prices in line with President Donald Trump’s Most Favored Nation scheme.
The FDA handed out the first batch of tickets in October last year, with Tzield and bitopertin among them. Lilly and Boehringer won their tickets during the second cycle of awards in November. The FDA has since proactively handed out a voucher to Johnson & Johnson—the pharma didn’t apply for the award.
