On Wednesday, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s new weight-loss pill, marking a major development in the competitive market for GLP-1 therapies. The drug, known as orforglipron and marketed under the brand name Foundayo, is a once-daily oral medication designed to target the GLP-1 hormone, which plays a key role in appetite regulation and metabolism.
Clinical trials have shown promising results, with patients experiencing an average weight loss of 12% to 15% of their body weight. This approval positions Eli Lilly to compete directly with Novo Nordisk, another major player in the market, as millions of Americans seek effective, medically backed solutions for weight management.
Read Also – Lilly Strikes Up to $7.8 Billion Deal to Acquire Centessa, Expanding into Sleep Disorder Treatments
Lilly said it will begin selling Foundayo on April 6 through its LillyDirect program at a cost of $149 per month for the lowest dose for self-pay customers, on par with Novo’s pill. Soon after, it will be available through retail pharmacies and telehealth providers, the Indianapolis-based company said.
Lilly CEO David Ricks told reporters that the pill is intended for patients who want to lose weight or maintain weight loss, and he added that the company has already submitted applications for approval in more than 40 countries.
“We do expect approvals yet this year in several major markets. The Gulf states are one of those areas that tend to move a little quicker, so that would be one,” Ricks said.
LILLY VS NOVO
The FDA approval, which was fast-tracked under the agency’s new voucher program, positions Eli Lilly in direct competition with Danish pharmaceutical company Novo Nordisk.
Novo Nordisk was an early leader in the GLP-1 market with its injectable treatments, including Ozempic for diabetes and Wegovy for obesity, giving it a strong foothold in the U.S. market. Novo also gained a first-mover advantage in oral GLP-1 medications when it launched oral Wegovy in January, which quickly saw high demand.
In contrast, Lilly’s pill offers greater flexibility for patients: it can be taken at any time of day, with or without food, whereas the Wegovy pill must be taken first thing in the morning, at least 30 minutes before consuming food, water, or other medications. This difference could make Lilly’s treatment more convenient for patients seeking a simpler daily routine.
“In the early innings of the launch, investors will be following closely to see if Foundayo’s lack of a food effect drives any difference in patient uptake,” BMO analyst Evan Seigerman said in a research note.
PILLS VS INJECTABLES
According to Jamey Millar, an executive at Novo Nordisk U.S., most patients taking oral Wegovy are using a GLP-1 medication for the first time. This shows that oral pills could reach a part of the weight-loss market that injectables don’t currently serve.
Millar also noted that patients generally follow the pill’s instructions without problems, and that the cost of the medication and potential side effects are the biggest factors influencing their choice.
Oral weight-loss medications are not expected to completely replace injectable treatments, which can often provide larger reductions in body weight. However, analysts project that oral pills could capture roughly 20% of the weight-loss market by 2030.
Clinical trials of Eli Lilly’s oral GLP-1 drug, orforglipron, have shown promising results: in a 72-week late-stage study, participants lost about 12% of their body weight, with most reaching a plateau after initial weight loss. In an earlier 36-week mid-stage trial, orforglipron helped participants reduce their body weight by nearly 15%, demonstrating its potential as an effective oral option for individuals seeking weight-loss solutions.
The most frequently reported side effects of Foundayo were mild to moderate gastrointestinal issues, including nausea and vomiting.
The drug’s label also carries a boxed warning, the FDA’s most serious type of warning, highlighting a potential increased risk of thyroid C-cell tumors. Notably, Novo Nordisk’s oral and injectable Wegovy medications carry the same warning.
Foundayo was granted a voucher under the FDA Commissioner’s National Priority voucher program, which is designed to expedite regulatory decisions for drugs that address significant public health needs or national security concerns.
Lilly received this voucher as part of an agreement with the Trump administration aimed at reducing the cost of its weight-loss medications for government programs and for patients paying out-of-pocket.
FDA Commissioner Marty Makary told reporters the Lilly pill review was as thorough as the traditional longer process would have been. “What we’re doing is convening the different people at the agency that review parts of the application,” he said.
