Why Foundayo, the new single-use GLP-1 pill, is such a big deal

A new era of weight loss medication began Wednesday: The Food and Drug Administration has Eli Lilly’s GLP-1 oral pill approved for sale in the United States.

The approval for the drug, which will be sold under the brand name Foundayo, is an important technological inflection point for this class of drugs that the transformation of 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 stick it into their body to reap the weight-loss benefits.

It is difficult to estimate exactly how much Americans’ needle aversion has reduced their uptake of GLP-1 drugs. Other factors – esp costas well as concerns about long-term safety and side effectsand a preference for other weight loss tactics – 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 from last year) and the share who are obese (about 37 percent) suggests that there is a significant percentage of people who could benefit from these drugs but have not taken them.

It’s possible that some of those holdouts have been waiting for a more convenient option, without the hassle of a needle — and Lilly is betting that their new pill will make GLP-1s accessible to 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 on our Monday, Tuesday, Wednesday, Thursday tray and take it with our other oral medications without regard to food or most concerns about drug interactions or anything like that,” Eli Lilly CEO Dave Ricks told me in an interview last week. “It’s quite different from a weekly injection. Obviously, a lot of people use weekly injections 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 bit easier to fit into their busy lives.”

How that hope actually plays out now that the FDA has given its green light remains to be seen. And, as always, a new drug comes with some caveats and caveats. Here’s what you need to know.

Why Lilly’s GLP-1 drug is a big deal

If you’re thinking, “Wait, isn’t there already a GLP-1 pill?”, you’d be right—but there’s a catch.

Novo Nordisk received approval for his Wegovy weight loss pill in December, and it has been on the market for several months. But that drug is a peptidewhich delivers semaglutide in a large-molecule form, ie more difficult to manufacture and requires more care when taken. The company advise Patients should take their pill immediately upon waking, with 4 ounces of water, and then wait for at least 30 minutes before eating or drinking anything else.

The Lilly pill is a small-molecule drug — closer in shape to statins or blood pressure medication. This makes it cheaper to manufacture and avoids some of the drug interaction issues. The GLP-1 market is periodically hampered by deficitsand Lilly is betting that putting the drug in this new form will allow them to produce a more robust supply. As Ricks put it to me, “We can basically make as much as we need.”

“Since it’s in a pill and not an injection, which reduces the supply chain needs around plastic and cold storage, and it doesn’t have special instructions for taking it, it’s likely to become a popular choice for primary care (physicians) as they don’t have to demonstrate pen use, etc.,” Dr.

The pill form may also help mitigate one of the recurring challenges with GLP-1s: humans regain weight if they stop taking it. Injectables can be difficult to stick with over the long term: People get sick from the injections, they may find it difficult to stick to a once-weekly injection, they don’t want to worry about refrigeration when they travel, etc. A one-time pill that you can make part of your existing medication routine if needed could, in theory, make it easier for patients or GLP-1.

It is possible that we are in the middle of the “statinization” of GLP-1s. Just as statins have become a drug you take long-term to manage your cholesterol, a GLP-1 pill can become something you take for years to manage your weight. People may also switch to a lower dose over time or switch from an injectable to a pill to make the drug more of a maintenance drug to keep your weight stable.

“People often lose a lot of weight on Zepbound and reach their goal weight; maybe they lose about 50 pounds. And they’re like, ‘Okay, I don’t have to keep losing weight,'” Ricks said. “An option – and we’ve done the studies and it will be indicated within our label – is that you can switch to an oral form. And maybe that fits more easily into your life.”

What comes next for GLP-1s

Here’s what the Lilly pill doesn’t represent: a major advance in how effective these GLP-1 drugs are. In clinical trials, patients lost 12 percent of their body weight average, in line with the original Ozempic injection, but a smidge lower than Mounjaro, Zipboundand some of the most recent entries in this drug class. You’re not going to take the Lilly pill for its groundbreaking effectiveness: 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 within the next 45 days for $299. This is 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 made a deal with Medicare to cover the new pill and other GLP-1 treatments for a copay of $50 a month. He added that many insurance plans for higher earners have also begun 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 as the drugs show their long-term value in reducing not only obesity, but also associated conditions such as heart disease; As part of the company’s agreement with the U.S. government, the drug’s cost and health effects will be assessed over time by federal officials, Ricks said.

“It’s hard to imagine, if it’s 2030, and we have a lot of these medicines that we’ve proven the benefits for chronic diseases and the government has said it’s worth it after this two-year pilot that they’re doing – it’s hard to think of too many employers who will say, ‘It’s not for me,’ Ricks the government told me, “I think it’s a good thing. endorsement for insurance.”

Like people who use 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 alleviated by appropriate diet and exercise, but my own reporting suggest that not everyone receives the necessary support to avoid those negative consequences. The distribution of virtual pharmacies which largely exists to prescribe GLP-1s, with no other long-term patient-doctor relationship, adds to the risk of people using these drugs without appropriate supervision and support.

To really make the most of the GLP-1 drugs, the entire healthcare system needs to evolve to make that kind of holistic treatment the norm. But as GLP-1 use expands rapidly at the same time that access to primary care shrinks, it’s reasonable to worry whether overstretched clinicians will be able to adapt — or that many people will still be left to navigate their weight loss journey on their own.

And finally, it is not the last GLP-1 drug. New iterations is in the workswhich combine different ingredients to make the treatments more effective or to buffer unwanted side effects. The Lilly pill may not be the standard of care for long. GLP treatment can become highly personalized: As Horn put it to me, someone with obstructive sleep apnea may still want to take Zepbound because that drug has been proven effective for both that condition and weight loss at the same time.

She shared some questions that doctors and patients can consider together when deciding which GLP-1 will be right:

We are already seeing the so-called Ozempic effect obesity data. The US may finally be starting to turn the corner from one of our long-running 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 of the weight loss medications discussed are semaglutides.