Eli Lilly will submit orforglipron to be part of FDA’s new national priority voucher program, according to a new report.¹ The company believes it to be a strong candidate for the program.

What is the criteria to be included in FDA's national priority voucher program?

In order to meet the criteria for the program, Lilly would have to show evidence that the GLP-1 pill either addresses a health crisis or serves an unmet need. However, the announcement could signal Lilly’s plans to make a deal to include the drug on TrumpRx, which would also make it admissible to FDA’s new program.

Industry experts have previously speculated that the drug could included in FDA’s national priority voucher program.

Lilly announced the results of the Phase III trial for orforglipron in August of this year,² saying that the results showed that the drug helped trial participants lose an average of 22.9 lbs.

In a press release issued at the time, said Louis J. Aronne, MD, FACP, DABOM, founder and Chair Emeritus of the American Board of Obesity Medicine, said, “Based on my experience leading clinical trials in obesity and diabetes, these data show the potential for orforglipron to offer an efficacy, safety, and tolerability profile consistent with the injectable GLP-1 class. Orforglipron could help health care providers expand treatment options for patients who prefer oral therapies without compromising clinical results."

In the same press release, Lilly executive vice president and president of Lilly Cardiometabolic Health Kenneth Custer, PhD, added, “The ATTAIN-2 results reinforce the potential for orforglipron, as a once-daily oral, to deliver meaningful weight loss and A1C reduction, consistent with similar landmark trials for injectable GLP-1s. With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting. If approved, we are ready to offer a convenient, once-daily pill that can be scaled globally—removing barriers and redefining how obesity is treated around the world."

FDA’s priority review program was first announced in June of this year. In a statement issued at the time, Commissioner Makary explained, “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public. As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”

In October, FDA announced the first group of drugs to be included in the program. At the time, Makary said in a statement, “One of our core goals is to deliver more cures and meaningful treatments—especially ones that have an outsized impact on our most pressing national priorities. We must modernize the review process and try new approaches to meet the needs of the American people.”

The drugs announced at the time were:

• Pergoveris for infertility
• Teplizumab for Type I diabetes
• 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
• Augmentin XR for domestic manufacturing of a common antibiotic

Source

1. Eli Lilly says weight-loss pill a candidate for speedy approval under new US program. Reuters. October 31, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/eli-lilly-raises-full-year-forecast-sees-sustained-demand-weight-loss-drugs-2025-10-30/
2. Lilly's oral GLP-1, orforglipron, is successful in third Phase 3 trial, triggering global regulatory submissions this year for the treatment of obesity. Eli Lilly and Company. August 26, 2025. Accessed October 31, 2025. https://www.prnewswire.com/news-releases/lillys-oral-glp-1-orforglipron-is-successful-in-third-phase-3-trial-triggering-global-regulatory-submissions-this-year-for-the-treatment-of-obesity-302538028.html