The Food and Drug Administration has approved the 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 a choice of pills instead of injections from both makers of the leading obesity medicines. The pill options could appeal to many patients. But the cost of the drugs and limits on insurance coverage remain obstacles.
The agency approved Lilly's obesity pill on a fast track for drugs that FDA deems a national priority. The decision to approve Foundayo took 50 days, the agency said, and is the fastest for a brand-new kind of drug since 2002.
Even though Lilly is the same company behind Zepbound, the blockbuster injectable obesity medicine, Eli Lilly decided not to take Zepbound's main ingredient and make it in pill form. Instead, the company developed a new ingredient, known generically as orforglipron, that's not a peptide, like the injectable drugs, but acts like one.
That means the active ingredient is easier for the body to absorb in pill form, says Eli Lilly's chief scientific and product officer, Daniel Skovronsky.
"We've created a small molecule chemical which gets in your body very well," Skovronsky says. "It can mimic the effects of the peptide and can be taken more conveniently any time of day without any food or water restrictions."
Its competitor, the Wegovy pill is a peptide. Peptides are small chains of amino acids. The Wegovy pill has the same active ingredient as the injection with an added ingredient so it can be absorbed before the peptide is broken down by acid in the stomach. But, unlike Foundayo, the Wegovy pill has to be taken on an empty stomach and the patient has to fast for 30 minutes in order for it to work.
So for some people, Foundayo may be more convenient — and harder to mess up.
Data from one of the Lilly clinical trials the FDA reviewed 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 with 2.2 pounds, or 0.9% of average body weight, for those getting a placebo. The most common side effects were nausea, constipation and diarrhea.
Novo Nordisk came out swinging against the rival pill. "Not all GLP-1s are the same. Any reports claiming orforglipron is more effective than Wegovy pill for weight management are inaccurate and misleading," said a statement from Jamey Millar, executive vice president for U.S. operations of Novo Nordisk. "There is no head-to-head trial comparing the efficacy of orforglipron and Wegovy pill … ."
In clinical trials, the Lilly pill appeared a little less effective than its competition, though it wasn't tested head-to-head. How it works in the real world could be different, says Dr. Catherine Varney, the obesity medicine director for UVA Health in Charlottesville, Va.
She says she wouldn't be surprised if her patients taking the new pill lose more weight because this pill is easier to take, especially for people with complex medical regimens or people who struggle with strict dosing. "That's where, for example, one is going to have a little bit more of an advantage. So… to be determined," she says.
Lilly's Skovronsky says he expects Foundayo to appeal to patients who consider injections to be too big a step for them to take.
"I think ideally this medicine will be for people who haven't tried a weight loss drug yet," he says. "They're wondering whether they're sick enough, whether this disease is serious enough. Maybe they're worried about an injection not fitting into their life."
But Varney at UVA says her experience as a clinician has shown her patients aren't really put off by needles. "I can tell you of over the 1,000 patients that I have on GLP-1 therapy, not once has needle phobia been an issue," she says.
For her patients, the biggest barrier to getting care has been cost. She says all of her patients who are on the Wegovy pill versus injectable drugs are on them because they're more affordable.
The starting dose for Foundayo, like the Wegovy pill, is $149 a month for customers going outside their insurance and paying cash.For comparison, the cash price for Eli Lilly's obesity injection Zepbound is $299 a month. Both get more expensive at higher doses, but Foundayo is cheaper.
The company has not yet released a list price, which is the starting bid for insurance and what a patient's copay is usually based on.
Lilly says its insurance coverage will become clearer soon. But for people with commercial coverage, copays could be as low as $25 a month with an Eli Lilly savings card. And starting in July, people with Medicare coverage may be able to get it for $50 a month. Medicaid coverage could take some more time.
As for supply, the company has been manufacturing these pills for a while and should be able to meet demand. Skovronsky says he expects them to be on pharmacy shelves within a "week or two."
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