A new era of weight loss medication began on Wednesday: The Food and Drug Administration has approved Eli Lilly’s GLP-1 oral pill for sale in the United States.
The approval for the drug, which will be sold under the brand name Foundayo, marks an important technological inflection point for this class of drugs that is transforming obesity care in the US and around the world. The previous generation of GLP-1 treatments were injections: Patients (or their doctors) had to handle a needle and insert it into their body in order to reap the weight-loss benefits.
It’s hard to estimate exactly how much Americans’ needle aversion has tamped down their uptake of GLP-1 drugs. Other factors — especially costs, as well as concerns about long-term safety and side effects, and a preference for other weight-loss tactics — have undoubtedly played a role, based on patient surveys. But the gap between the share of Americans who have tried a GLP-1 drug (about 12 percent as of last year) and the share who are obese (about 37 percent) suggests there is a sizable percentage of people who could benefit from these drugs but have not been taking them.
It’s possible some of those holdouts were waiting for a more convenient option, without the hassle of a needle — and Lilly is betting their new pill will make GLP-1s accessible for many of them.
“This is an oral medication in the sense that we’re used to an oral medication that we can just put it in our Monday, Tuesday, Wednesday, Thursday tray and take it with our other oral medications without regard to food or most worries about drug interactions or anything like that,” Eli Lilly CEO Dave Ricks told me in an interview last week. “That’s pretty different from a weekly injectable. Obviously, a lot of people use weekly injectables very successfully. But what we’ve learned, I think, is that there are a lot of people waiting for something like this. It’s just a little easier to fit into their busy life.”
How those hopes play out in reality now that the FDA has given its green light remains to be seen. And, as always, a new drug comes with some caveats and tradeoffs. Here’s what you need to know.
Why Lilly’s GLP-1 drug is a big deal
If you are thinking, “Wait, isn’t there already a GLP-1 pill?”, you’d be right — but there is a catch.
Novo Nordisk received approval for its Wegovy weight-loss pill in December, and it’s been on the market for a few months. But that drug is a peptide, delivering semaglutide in a large-molecule form that is harder to manufacture and requires more care when taking it. The company advises patients to take their pill immediately upon waking up, with 4 ounces of water, and to then wait for at least 30 minutes before eating or drinking anything else.
The Lilly pill is a small-molecule drug — closer in form to statins or blood-pressure medications. That makes it cheaper to manufacture and avoids some of the drug interaction concerns. The GLP-1 market has been periodically hampered by shortages, and Lilly is betting that putting the drug into this new form will allow them to produce a more robust supply. As Ricks put it to me: “We can make basically as much as we need.”
“Given it is in a pill and not an injection, which reduces supply chain needs around plastics and cold storage, and that is does not have special instructions to take it, it is likely to become a popular choice for primary care [physicians] as they won’t have to demonstrate pen usage, etc.,” Dr. Deborah Horn, medical director for the UT Physicians Center for Obesity Medicine and Metabolic Performance, who has consulted for Lilly, told me over email.
You’re not going to take the Lilly pill for its groundbreaking efficacy: Its convenience is the real pitch.
The pill form could also help mitigate one of the recurring challenges with GLP-1s: people regaining weight if they stop taking it. Injectables can be difficult to stick with over the long term: People get sick of the shots, they might find it hard to stay on top of a once-weekly injection, they don’t want to have to worry about refrigeration when traveling, etc. A once-a-day pill that you can make part of your existing medication routine could, in theory, make it easier for patients to stay on a GLP-1 if that’s appropriate or necessary.
It’s possible that we are in the midst of the “statin-fication” of GLP-1s. Much like statins have become a drug you take long-term to manage your cholesterol, a GLP-1 pill might become something you take for years to manage your weight. People could also potentially shift to a lower dose over time or switch from an injectable to a pill to make the drug more of a maintenance med to keep your weight stable.
“People often lose a lot of weight on Zepbound and get to their goal weight; maybe they lose about 50 pounds. And they’re like, ‘Okay, I don’t need to keep losing weight,’” Ricks said. “An option — and we’ve done the studies and it’ll be indicated within our label — is you can switch to an oral form. And maybe that fits into your life more easily.”
What comes next for GLP-1s
Here’s what the Lilly pill does not represent: a major advance in how effective these GLP-1 drugs are. In clinical trials, patients lost 12 percent of their body weight on average, in line with the original Ozempic injection, but a smidge lower than Mounjaro, Zepbound, and some of the more recent entries into this drug class. You’re not going to take the Lilly pill for its groundbreaking efficacy: Its convenience is the real pitch.
Cost and equitable access are ongoing challenges. Lilly plans to debut the pill at $149 for a month’s supply of the lowest dose, and refills will then be available for $299 within the next 45 days. That’s lower than the initial price point for a month of Wegovy injections available through Costco, for example, but still potentially out of reach for some patients. Ricks told me that Lilly has struck a deal with Medicare to cover the new pill and other GLP-1 treatments for a copay of $50 per month. He added that many insurance plans for higher earners have also started to cover GLP-1 drugs.
But insurance coverage for lower-income Americans, whether on private insurance or Medicaid, remains spotty. Ricks is hopeful that more insurers will come around as the drugs show their long-term value in reducing not only obesity but its associated conditions like heart disease; as part of the company’s deal with the US government, the drug’s cost and health effects will be assessed over time by federal officials, Ricks said.
“It’s hard to think, if it’s 2030, and we have many of these medicines that we’ve proven the benefits for chronic diseases and the government said it’s worth it after this two-year pilot they’re doing — it’s hard to think of too many employers who would say, ‘That’s not for me,” Ricks told me. “If [the government says] it’s worth it, I think that’s a pretty ringing endorsement for insurance.”
Like folks using the injections, some people who took the pill in clinical trials reported unwanted side effects, including gastrointestinal distress and debilitating muscle loss. Those symptoms can often be mitigated through appropriate diet and exercise, but my own reporting suggests that not everyone is receiving the necessary support to avoid those negative consequences. The proliferation of virtual pharmacies that exist largely to prescribe GLP-1s, with no other long-term patient-doctor relationship, adds to the risk that people go on these drugs without appropriate supervision and support.
To truly make the most of the GLP-1 drugs, the entire health care system needs to evolve to make that kind of holistic treatment the norm. But as GLP-1 use rapidly expands at the same time access to primary care is shrinking, it is reasonable to worry whether overstretched clinicians will be able to adapt — or whether many people will still be left to navigate their weight-loss journey on their own.
And finally, this is not the last GLP-1 drug. New iterations are in the works, combining different ingredients to make the treatments more effective or to tamp down on undesirable side effects. The Lilly pill may not be the standard of care for long. GLP-treatment could start to become highly personalized: As Horn put it to me, somebody with obstructive sleep apnea may still want to take Zepbound because that drug has proven effective for both that condition and weight loss at the same time.
She shared a few questions doctors and patients might consider together when deciding which GLP-1 would be right:
We are already seeing the so-called Ozempic effect in obesity data. The US may be finally starting to turn the corner on one of our longstanding health crises. A GLP-1 pill offers a chance to push that progress even further — if we can figure out how to expand access and how to better support patients so they can lose weight in a healthy way.
Clarification, April 1, 4:15 pm ET: A previous version of this post referred to the “semaglutide revolution.” The story has been updated to clarify that not all the medications for weight loss discussed are semaglutides.
