FDA approves new obesity pill, giving patients another option

The Food and Drug Administration has approved a second GLP-1 pill to treat obesity, this time from drugmaker Eli Lilly.

The new pill, Foundayo, is taken once a day and will compete with the pill form of Wegovy, made by Novo Nordisk, which was approved by the FDA in December.

Patients now have the option of pills instead of injections from both leading obesity drug manufacturers. The pill option can be appealing to many patients. But drug costs and insurance limits remain obstacles.

The agency approved Lilly’s obesity pill on the fast track for a drug deemed a national priority. The decision to approve Foundayo took 50 days, the agency said, and was the fastest for a new type of drug since 2002.

Although Lilly is the same company behind Zepbound, the blockbuster injectable obesity drug, Eli Lilly decided not to take Zepbound’s main ingredient and make it in pill form. Instead, the company developed a new material, commonly known as orforglipron, that is not a peptide, like an injectable drug, but acts like one.

That means the active ingredients are more easily absorbed by the body in pill form, said Eli Lilly’s chief scientific and product officer, Daniel Skovronsky.

“We’ve created a small chemical molecule that goes into your body,” Skovronsky said. “It can mimic the effects of peptides and can be used better at any time of the day without food or water restrictions.”

The competitor, Wegovy pill is a peptide. Peptides are small chains of amino acids. Wegovy pills have the same active ingredients as the injection with added ingredients so they can be absorbed before the peptides are broken down by acid in the stomach. However, unlike Foundayo, the Wegovy pill must be taken on an empty stomach and the patient must fast for 30 minutes for it to work.

So for some people, Foundayo may be more convenient – and harder to screw up.

Data from one of Lilly’s clinical trials reviewed by the FDA found that patients who took the highest dose of Foundayo as directed for 72 weeks lost an average of 27.3 pounds, or 12.4% of their body weight, compared to 2.2 pounds, or 0.9% of their body weight on average, for those who received placebo. The most common side effects are nausea, constipation and diarrhea.

Novo Nordisk comes out swinging against rival pills. “Not all GLP-1 is the same. Any report that says orforglipron is more effective than Wegovy pills for weight management is inaccurate and misleading,” said a statement from Jamey Millar, executive vice president for Novo Nordisk’s US operations. “There is no head-to-head trial comparing the efficacy of orforglipron and the pill Wegovy … .”

In clinical trials, Lilly’s pill appeared to be less effective than its competitors, although it was not directly tested. How it works in the real world may be different, says Dr. Catherine Varney, director of obesity medicine for UVA Health in Charlottesville, Va.

He said he wouldn’t be surprised if his patients taking the new pill lose more weight because it’s easier to take, especially for people with complicated medical regimens or those who struggle with strict dosages. “That’s where, for example, one will have a little more than one advantage. So … if determined,” he said.

Lilly’s Skovronsky said he hopes Foundayo will appeal to patients who consider injections too big a step for them.

“I think ideally this drug will be for people who have not tried weight loss drugs yet,” he said. “They’re wondering if they’re sick enough, if this disease is serious enough. Maybe they’re worried about an injection that doesn’t fit into their lives.”

But Varney at UVA said her experience as a doctor has shown her patients aren’t really put off by needles. “I can tell you over 1,000 patients I’ve had GLP-1 therapy with, not once has needle phobia been a problem,” he says.

For his patients, the biggest barrier to getting treatment is cost. He says that all of his patients who are on Wegovy pills versus injectables are on them because they are cheaper.

The starting dose for Foundayo, like the Wegovy pill, is $149 a month for customers outside their insurance and paying cash. For comparison, the cash price for Eli Lilly’s obesity injection Zepbound is $299 a month. Both become more expensive at higher doses, but Foundayo is cheaper.

The company has not yet released list prices, which are the initial bids for insurance and what patient copays are typically based on.

Lilly says its insurance coverage will be clearer soon. But for people with commercial coverage, copays can be as low as $25 a month with the Eli Lilly savings card. And starting in July, people with Medicare coverage can get it for $50 a month. Medicaid coverage may take some time.

As for the supply, the company has been making these pills for a while and should be able to meet the demand. Skovronsky said he expects them to be on pharmacy shelves in “a week or two.”