Action marks the fastest approval of an NME since 2002
The U.S. Food and Drug Administration today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher (CNPV) pilot program. Issued 50 days after filing — and 294 days before the application’s PDUFA date of January 20, 2027 — this decision represents a historic milestone as the first new molecular entity (NME) approved under the program. It is also the fastest approval of an NME since 2002.
Foundayo is approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
“This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work from the agency and industry partners,” said FDA Commissioner Martin Makary, M.D., M.P.H. “By cutting idle time and maintaining constant communications with the company throughout the review process, we completed this national priority review with outstanding efficiency, while upholding the FDA’s gold-standard science. This reflects the level of performance the public should expect from the FDA.”
Launched in 2025, the CNPV pilot program seeks to expedite approval of applications that address critical national health priorities. The agency has awarded 18 vouchers and issued six decisions so far. Benefits of the program include enhanced communications and rolling review to allow for a shortened review time without compromising safety. The FDA's target timeline for decisions under the program is two months, with provisions for extended review periods when determined necessary by the agency's scientific reviewers.
Foundayo is a glucagon-like peptide-1 (GLP-1) receptor agonist in tablet form that should be taken orally once daily. Starting dosage is 0.8 mg, which should be increased to 2.5 mg after at least 30 days and then to 5.5 mg after another 30 days. The dosage may be increased further to 9 mg, 14.5 mg, or 17.2 mg after at least 30 days at each level based on treatment response and tolerability.
“The approval of orforglipron is another example of how the FDA’s CNPV pilot program has been able to more quickly bring effective treatments to Americans. Individuals who are overweight or obese now have an additional option to help with weight loss — a GLP-1 receptor partial agonist pill which does not need to be taken on an empty stomach,” said Acting Center for Drug Evaluation and Research (CDER) Director Tracy Beth Høeg, M.D., Ph.D. “The CDER review team delivered a thorough, high-quality product review and benefit-risk analysis, while simultaneously taking months off the standard filing-to-decision time.”
Two randomized, double-blind, placebo-controlled trials in adults with obesity or with overweight and one or more weight-related comorbidities supported the approval of Foundayo. In these trials, 72 weeks of treatment with Foundayo, in combination with a reduced calorie diet and increased physical activity, resulted in a statistically significant and clinically meaningful reduction in body weight in the Foundayo treated groups compared with the placebo group.
Foundayo can cause side effects such as nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal (stomach) pain, headache, abdominal extension, fatigue, burping, gastroesophageal reflux disease, gas, and hair loss. It also contains warnings and precautions for inflammation of the pancreas (pancreatitis), severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia (blood sugar that is too low), hypersensitivity, diabetic retinopathy (damage to the eye’s retina) in patients with type 2 diabetes mellitus, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation. It should not be used in combination with another GLP-1 receptor agonist.
The labeling for Foundayo includes a boxed warning for thyroid C-cell tumors. Foundayo should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2.
The FDA will host a public meeting on June 4 (rescheduled from June 12) to solicit feedback about the CNPV program’s eligibility criteria, the voucher selection process, sponsors responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV review council, and program implementation. Interested parties may also submit written comments through June 29, 2026.
The FDA granted the approval to Eli Lilly and Company.
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