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Lilly’s Orforglipron Considered ‘Prime Candidate’ for New FDA Fast Track Approval Program: Report
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Key Takeaways
- The FDA's new program could expedite Orforglipron's approval, reducing review time to 1-2 months for high-burden condition treatments.
- Orforglipron, a non-peptide oral GLP-1 receptor agonist, has shown success in Phase III trials, offering a valuable alternative to injectable GLP-1 therapies.
Eli Lilly's Orforglipron may become the first drug fast-tracked under the FDA's new program, promising quicker access for weight loss treatment.
The experimental GLP-1 could be fast tracked through a one-to-two-month process to accelerate its approval in the U.S.
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Eli Lilly and Company’s experimental weight loss GLP-1 Orforglipron has potential to be fast tracked to approval under the new FDA program. The Commissioner’s National Priority Voucher is a new program expected to accelerate the agency’s approval process and new reports suggest that Lilly’s Orforglipron might be its first test.
According to a report from Reuters, Jefferies analyst Akash Tewari touched on the possibility of Orforglipron being the programs first candidate in a recent research note, saying, "We think Orforglipron is a prime candidate for this pilot program as it treats a high-burden chronic condition and can be priced at parity."1
What is the new FDA program?
Back in July of this year, FDA disclosed the terms of its new program The Commissioner’s National Priority Voucher, allowing for experimental drugs meeting certain criteria to be approved within an expedited process ranging from one to two months. This process is much faster than FDA’s standard review process which typically takes around 10 months. The program is also part of FDA’s plan to streamline its drug reviews, along with its attempt to adhere to President Donald Trump’s goal of lowering pharmaceutical pricing.
Chad Landmon, chair of Polsenelli's patent and FDA practice touched on the improved approval program, saying, "FDA policymakers have tried to come up with ideas to speed important products to market... It is in part directed to achieving some of the Trump Administration's goals.”1
What benefits does the program give to Orforglipron?
Lilly touched on the new program’s potential in an emailed statement to Reuters, saying, “the new FDA program is a promising initiative," but continued to say it was "too early to discuss how this submission pathway might relate to any of our specific programs."1 Along with Lilly’s statement on the new program, Goldman Sachs estimated that if the program does allow Orforglipron to release a quarter before its anticipated release, it could generate nearly another $1 billion in revenue for the company. As of now Lilly is planning on submitting Orforglipron for review later this year, with CEO Dave Ricks telling CNBC back in August, that he expects the oral pill to be available worldwide around “this time next year,” following the drugs successful completion of its third Phase III trial.
What is Orforglipron?
Orforglipron is an investigational daily small molecule, non-peptide oral glucagon-like peptide-1 receptor agonist, with the ability to be taken any time of the day without food or water restrictions.2 After recent success in its Phase III trial testing, Orforglipron displayed its potential to be valuable GLP-1 option for both patients and physicians.
"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," said Louis J. Aronne, MD, FACP, DABOM, founder and chair emeritus of the American Board of Obesity Medicine, former president of The Obesity Society, fellow of the American College of Physicians, and world-renowned obesity specialist. Aronne continued, saying, "Orforglipron could help health care providers expand treatment options for patients who prefer oral therapies without compromising clinical results."2
Sources
- Lilly weight-loss pill could be FDA-approved by year-end Reuters September 16,2025 https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-weight-loss-pill-could-be-fda-approved-by-year-end-2025-09-16/
- 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 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
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