The United States Food and Drug Administration on Monday authorized a once-a-day pill form of Novo Nordisk’s weight-loss drug Wegovy, unveiling a new way that patients can take medications in a class of drugs that is transforming the treatment of obesity.
Novo Nordisk calls the Wegovy pill simply that, while it has labeled the original Bigwig from which the diabetes drug and contrave are made Ozempic.
Bother Wegovy and Ozempic, like the hormone GLP-1 they mimic, are used as a weekly injection, as are competitors from Eli Lilly called Zepbound and Mounjaro. In total, roughly 1 in 8 US adults say they are currently taking one of these two drugs, according to data from the health policy research group KFF.
Clinical trials found the Wegovy pill to be nearly as effective and side effects were similar to those experienced by patients who used the Wegovy shot, Novo Nordisk said, adding that it would be available by prescription in this country starting in January.
With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins https://t.co/enSzpfxPk3 pic.twitter.com/vA0xB2OVfu
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“We see it as broadening access and options for patients,” Dr. Jason Brett, principal US medical head at Novo Nordisk, told CNN in an interview. “We know there are certain patients who simply will not accept an injectable.”
The Wegovy pill will start with a list price of $149 for cash pay patients, as part of a deal announced in November with the Trump administration. The drug will also tend to become more expensive directly out-of-pocket as doses ramp up, though Novo hasn’t yet published those prices. Patients who have insurance that covers the drug are expected to pay less in copayments.
The Wegovy pill is one of two oral GLP-1 drugs that are likely to come on the market within months; Lilly also has a drug, known as orforglipron — until it gets a brand name — that is expected to be approved by the F.D.A. this summer.
The pills have not been directly compared in a clinical trial, but in separate studies, people who took the Wegovy pill lost an average of 14 percent of their weight over 64 weeks, compared with 2 percent for people assigned to take a placebo; while those taking orforglipron lost an average of 11 percent on its highest dose after 72 weeks, also compared with 2 percent among those receiving a placebo. In its main trial, Wegovy injection led to 15 percent loss in body weight compared with 2 percent for those who received a placebo, and Zepbound had an effect of around 21 percent in patients on its highest dose versus about 3 percent among those on the placebo.
With the GLP-1 drugs, gastrointestinal side effects — mainly nausea and vomiting — have been seen in studies of the pills as well. All told, 7 percent of participants in the trial testing Wegovy as a pill stopped treatment because of side effects, compared with 6 percent who were treated with placebo. Among patients treated with orforglipron, up to 10 percent discontinued their treatment, compared with 3 percent on placebo.
One distinction between the medications is that the Wegovy pill needs to be taken on an empty stomach with a small quantity of water, and patients are told not to eat, drink or take other drugs for at least 30 minutes after taking it. Semaglutide in the form of a pill, approved for diabetes as Rybelsus, has not been used as much as Ozempic at least partly for that reason, doctors say.
Lilly emphasizes that in clinical trials, orforglipron was taken once daily at any time, without regard to food or water.
That value proposition could work in Lilly’s pill’s favor if and when it is approved, said Evan Seigerman, a Wall Street financial analyst who covers both companies closely for the stock research house BMO Capital Markets.
He expects that doctors and patients could particularly use pills to maintain weight, after a plateau on injectable drugs. Lilly demonstrated in clinical trial results that were recently disclosed that patients who switched to orforglipron after losing weight on either Wegovy or Zepbound regained less of it than those who took a placebo instead.
To Dr. Judith Korner, an endocrinologist and the director of the Metabolic and Weight Control Center at Columbia University Vagelos College of Physicians and Surgeons, there are three main factors when considering whether a new drug is appropriate for her patients: how well it works, how safe and tolerable it is to take, and what its cost will be.
“The Wegovy pill doesn’t appear to be moving the needle that much with respect to any of the above,” Korner said in an email to CNN.
And whereas the price tag of $149 for the starting dose might be cheaper than what the companies are already charging for their injectable drugs, that’s only for the initial, least potent dose. Those drugs are designed to begin at a low dose and allow patients to slowly increase their dose over time, to mitigate side effects; the Wegovy pill will be available in doses of 1.5 milligrams, 4 milligrams, 9 milligrams and an anticipated long-term dose of 25 milligrams, Brett said.
“It’s really quite clear that the lowest dose is virtually never what people end up needing to be on,” said Korner. “That’s kind of like a loading dose, to make the side effects of it little less by being used to it.”
Lilly, which introduced the administration’s price as a base price in the Trump agreement, will charge up to $149 for additional doses of orforglipron and may charge as much as $399 if patients are paying cash.
Korner does welcome greater choices for patients within a category of medications that has been shown to be useful beyond weight loss.
“It’s that we start to see these benefits, like for cardiac disease — 20% reduction in death or another event — or sleep apnea, heart failure reduced; liver function improved,” Korner said, “that’s to me the exciting part.”
