FDA Approves New Type of GLP-1 Pill for Weight Loss

0
191

The U.S. Food and Drug Administration (FDA) has approved a new type of GLP-1 weight loss pill that, unlike the Wegovy pill, can be taken at any time of day without restrictions on food or water intake.

The new pill, Foundayo (orforglipron), won FDA approval to aid weight loss in adults with obesity or those who are overweight and have weight-related health problems, drugmaker Eli Lilly said in a statement.

The company said it plans to seek FDA approval for the pill as a treatment for type 2 diabetes later this year.

What Makes Foundayo Unique

Like other newer diabetes and obesity medications, orforglipron mimics the hormone GLP-1, which plays a role in appetite regulation. This hormone helps to slow digestion and promote feelings of fullness, which reduces appetite.

What sets Foundayo apart from other GLP-1s is that it’s a “small molecule” drug — the first GLP-1 in this category — that can easily enter the bloodstream through the digestive system, even right after a meal. By contrast, the Wegovy pill is a peptide-based “large molecule” drug that is more difficult for the body to absorb, requiring that a person take it on an empty stomach.

While patients will still need to find a consistent time of day to take Foundayo, being able to choose what works best in their schedule without worrying about proximity to meal times may make this drug easier to stick with than the Wegovy pill, says Melanie Jay, MD, a professor at the New York University Grossman School of Medicine and director of the NYU Langone obesity research program.

“For many people, a daily pill with no timing rules will feel easier and more normal, which could help adherence,” Dr. Jay says.

How Foundayo Weight Loss Results Compare With the Wegovy Pill

In a late-stage clinical trial, researchers focused on adults with overweight or obesity who didn’t have type 2 diabetes. Participants took one of three doses of orforglipron or a placebo for 72 weeks.

By the end of the study, people on the highest dose lost an average of about 27 pounds (12.4 percent of their starting body weight), compared with average weight loss of just 2.2 pounds with the placebo.

In comparison, adults taking the highest dose of the Wegovy pill in clinical trials lost 13.6 percent of their starting body weight on average after 64 weeks.

Participants on all doses of Foundayo also experienced meaningful reductions in heart disease risk factors, Lilly said, including waist size, cholesterol and triglycerides levels, and blood pressure.

How Weight Loss on Foundayo Compares With Injectable GLP-1s

Average weight loss for adults taking Foundayo was comparable with results from what was until recently the highest dose of the Wegovy shot, 2.4 milligrams (mg). Participants in clinical trials of injectable Wegovy lost roughly 15 percent of their body weight on average.

However, a significantly higher-dose (7.2 mg) version of the Wegovy shots called Wegovy HD helped patients lose about 21 percent of their body weight on average over 72 weeks. Wegovy HD won FDA approval in March.

Another FDA-approved injectable GLP-1 made by Eli Lilly, Zepbound (tirzepatide), helped adults with obesity lose an average of about 21 percent of their starting body weight over 72 weeks when taken at the highest dose.

Side Effects of the New GLP-1 Pill

Foundayo’s most common side effects were mild to moderate and involved gastrointestinal issues. In a late-stage clinical trial, about 10 percent of adults on the highest dose and 5 percent on the lowest dose stopped taking the drug due to side effects.

With the highest dose, one-third of adults reported nausea, and roughly one-quarter had constipation, diarrhea, or vomiting.

These side effects are similar to what patients experience when taking the Wegovy pill.

How Much Will Foundayo Cost?

Lilly said Foundayo will be available through its LillyDirect platform immediately (prescriptions required) and will start shipping April 6. “Shortly after,” the new pill will be broadly available through brick and mortar pharmacies and telehealth providers.

Patients opting for self-pay will be able to get Foundayo starting at $149 for the lowest dose, Lilly said.

Those covered through Medicare Part D may be able to get Foundayo for $50 per month, starting as soon as July 1, 2026.

For patients with commercial insurance, Foundayo could cost as little as $25 per month when purchased with a discount card being offered by Lilly — although the final cost will likely vary, says Marilyn Tan, MD, a professor and endocrinologist at the Stanford University School of Medicine in California.

“Insurance coverage and copays will depend on many factors, such as specific insurance plans, formularies, and the medical indication for the drug,” Dr. Tan says.

Similar drugmaker discounts are available for the Wegovy pill, with monthly costs as low as $25 for insured patients and $149 for self-pay.

More Medications Mean More Choice

Now that there are multiple GLP-1 drugs for obesity, including more than one pill for people with an aversion to needles, patients can really make a choice based on what’s most convenient and affordable — and achieve meaningful weight loss with any option they select, Jay says.

Some people who find it difficult to travel with medicines that need refrigeration, as injected GLP-1s require, might want a pill, and some people who prefer a pill they don’t want to time based on their last meal might opt for Foundayo as the best option, Jay says.

However, people who want to achieve maximum weight loss may want to consider injected obesity drugs like Wegovy HD and Zepbound, which produce more dramatic weight loss results than FDA-approved GLP-1 pills, Jay adds.

It will take time and more study to ultimately determine which people benefit most from Foundayo compared with alternatives. “We don’t know yet if it is better or worse,” Jay says. “But I’d frame orforglipron as another important option in obesity care.”

LEAVE A REPLY

Please enter your comment!
Please enter your name here