Eli Lilly is celebrating another feather in its obesity drug cap with the highly awaited FDA approval of its oral GLP-1 treatment Foundayo (orforglipron) for adults with obesity or overweight conditions.
The approval marks the first new molecular entity (NME) approved under the FDA Commissioner’s National Priority Voucher (CNPV) pilot program.
The FDA said the decision, made 50 days after filing, is the fastest NME approval since 2002.
Related: Wegovy HD Receives FDA Approval as Fourth Product Under National Priority Voucher Program
Lilly’s Obesity Pill Orforglipron Helps Maintain Weight Loss After Switch from Injectable GLP-1s
FDA Commissioner Martin Makary emphasized the efficiency achieved through the controversial CNPV program, which aims to expedite reviews for critical health priorities. The program has issued 18 vouchers and six decisions since its 2025 launch, focusing on enhanced communication and rolling reviews. Foundayo is the fifth product approved under the scheme.
Approved just months after Novo Nordisk’s oral Wegovy (semaglutide), Foundayo is poised for rapid market accession and is anticipated to curb the pill’s early momentum.
Foundayo is a GLP-1 receptor agonist designed to mimic the activity of the incretin hormone glucagon-like peptide-1, which regulates appetite, food intake and satiety. It is intended for use with diet and exercise to aid weight reduction.
Unlike earlier peptide-based GLP-1 therapies, the drug’s oral formulation allows for flexible dosing without food or timing restrictions, addressing key adherence challenges associated with both injectables and earlier oral therapies.
The approval followed results from the ATTAIN clinical trial program involving thousands of patients, in which Foundayo demonstrated clinically meaningful and lasting weight loss. Patients receiving the highest dose achieved an average reduction of 27.3 pounds (12.4% of total body weight) compared to 2.2 pounds (0.9%) with placebo. Irrespective of completing a trial, individuals who took Foundayo lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.
Across all doses, Foundayo also led to reductions in various markers of cardiovascular risk, such as waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure.
“Today, fewer than 1 in 10 people who could benefit from a GLP-1 are taking one, held back by access, stigma, perceived complexity or the belief that their condition isn’t serious enough for treatment. We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications,” said Eli Lilly Chair and CEO David A. Ricks in a statement from the company. “As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world.”
Earlier this year, Eli Lilly shared results from the Phase III Attain-Maintain trial that showed it can help patients maintain weight loss after transitioning from injectable treatments like Wegovy or the company’s first approved obesity GLP-1 Zepbound (tirzepatide), with significantly less weight regain compared to placebo.
Eli Lilly and Novo Nordisk have generated multibillion-dollar revenues from their weight loss blockbusters, with their next set of obesity therapies focused on oral formulations and higher-dose options. Novo Nordisk recently secured FDA approval for Wegovy HD, a 7.2 mg high-dose version of its injectable therapy, which it plans to launch in April. Wegovy HD also received approval under the CNPV program.
Although Novo Nordisk was first to market with both injectable Wegovy and its oral formulation, it has taken a backseat to Eli Lilly in its share of the US obesity market.
The CNPV program has drawn growing scrutiny over concerns of transparency, scientific rigor and the potential for political influence in regulatory decision-making.
In a November 2025 letter, House Energy and Commerce Committee and Senate HELP Committee Democrats, including Democratic New Jersey Rep. Frank Pallone Jr. and Independent Vermont Senator Bernie Sanders, warned that the program, which does not have Congressional approval, could allow products to bypass established review pathways, raising questions about safety and efficacy standards being potentially compromised.
They also expressed “significant concerns that this program will enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump.” They also said the program could undermine public confidence in the FDA’s decisions and raise safety concerns, “including rushed reviews by an agency whose staff have been decimated by this administration’s cuts.”
The FDA will hold a public meeting on June 4 to discuss the CNPV program’s implementation, with written comments accepted until June 29, 2026.
Meanwhile, Eli Lilly has “committed to making Foundayo accessible and affordable” for patients. Those eligible with commercial insurance could pay as little as $25 per month with a Foundayo savings card. Eligible Medicare Part D beneficiaries may also be able to obtain the therapy for as little as $50 per month, with availability expected as early as July 1, 2026. Individuals paying out of pocket can access Foundayo starting at $149 per month for the lowest dose.
Eli Lilly said it expects the drug to be broadly available through US retail pharmacies and telehealth providers shortly after launch on LillyDirect, the company’s digital healthcare platform that includes an online pharmacy.
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