With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins
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The U.S. Food and Drug Administration has given the green light to a new form of the weight-loss medication Wegovy, now available as a daily pill. This approval marks a significant development for Novo Nordisk, offering patients a fresh and convenient way to benefit from a class of drugs that has transformed obesity treatment.

This new daily pill version of Wegovy contains the same active ingredient, semaglutide, which is the key component in both the original Wegovy and its counterpart diabetes medication, Ozempic.

Traditionally, both Wegovy and Ozempic have been administered through weekly injections. These medications, which mimic the hormone GLP-1, have counterparts from Eli Lilly known as Zepbound and Mounjaro. According to research by the health policy group KFF, approximately 1 in 8 adults in the U.S. are currently taking one of these medications.

Clinical trials for the Wegovy pill indicated that it achieves similar weight loss outcomes and side effects as its injectable predecessor. Novo Nordisk plans to make this pill available by prescription in the U.S. starting January.

“We believe it will expand access and options for patients,” stated Dr. Jason Brett, the principal U.S. medical head for Novo Nordisk, in an interview with CNN. He emphasized that some patients prefer to avoid injectable medications, and this new option could cater to their preferences.

The starting dose of the Wegovy pill will cost $149 for patients paying out of pocket, under an agreement announced in November with the Trump administration. The drug will likely become pricier via self-pay as doses increase, though Novo Nordisk hasn’t disclosed those prices yet. Patients whose insurance covers the medicine will likely have a lower copay.

The Wegovy pill is one of two oral GLP-1 drugs expected to hit the market in the next few months; the other, from Lilly, is called orforglipron – until it receives a brand name – and is expected to be cleared by the FDA by summer.

The pills haven’t been compared head-to-head in a clinical trial, but in separate studies, the Wegovy pill showed average weight loss of 14% over 64 weeks, compared with 2% for a placebo, while orforglipron showed 11% weight loss over 72 weeks on its highest dose, compared with 2% for the placebo group. Wegovy injection showed weight loss of 15% in its key trial, versus 2% for placebo, while Zepbound showed 21% on its highest dose, compared with 3% for those on placebo.

Gastrointestinal issues such as nausea and vomiting are the most commonly experienced side effects with GLP-1 drugs, which was seen in studies of the pills as well. Overall, 7% of participants in the Wegovy pill trial stopped treatment because of side effects, versus 6% on placebo. In orforglipron’s study, up to 10% of patients stopped treatment, compared with 3% on placebo.

One difference between the medicines is that the Wegovy pill must be taken on an empty stomach with a small amount of water, and patients are directed not to eat, drink or take other medicines for 30 minutes after taking it. A pill version of semaglutide approved for diabetes, called Rybelsus, hasn’t been used as widely as Ozempic in part for that reason, doctors say.

Lilly touts that, in clinical trials, orforglipron was taken once a day at any time, without restrictions on food or water.

That convenience factor may tip scales in favor of Lilly’s pill, if and when it’s approved, said Evan Seigerman, a financial analyst who follows both companies closely for Wall Street firm BMO Capital Markets.

He anticipates that doctors and patients may especially turn to pills for weight maintenance, after reaching a weight-loss plateau on injectable drugs. Lilly showed in recently announced clinical trial results that patients who switched to orforglipron after losing weight on either Wegovy or Zepbound regained less weight than participants who switched to a placebo.

To Dr. Judith Korner, an endocrinologist and director of the Metabolic and Weight Control Center at Columbia University Vagelos College of Physicians and Surgeons, there are three major considerations for assessing whether new medicines are right for her patients: how well they work, how safe and tolerable they are to take, and how much they cost.

“The Wegovy pill doesn’t seem to be moving the needle that much with regard to any of the above,” Korner told CNN.

While the price of $149 for the starting dose is lower than what the companies currently offer for the injectable drugs, that price is only for the initial, lowest dose. These medicines are designed to start at a low dose and have patients gradually ramp up over time, to manage side effects; the Wegovy pill will come in doses of 1.5 milligrams, 4 milligrams, 9 milligrams and the expected longer-term dose of 25 milligrams, Brett said.

“The lowest dose is almost never the dose that people wind up being on,” said Korner. “That’s just sort of like a loading dose, to let your body get used to it.”

Lilly, which will also offer the $149 starting price under the Trump agreement, says additional doses of orforglipron will cost up to $399 if patients are paying cash.

Korner does applaud having more options for patients in a group of medicines that’s proven to be beneficial beyond weight loss.

“As we start seeing these benefits, like for people who’ve had cardiac disease, 20% reduction in death or another event; reduction in sleep apnea; reduction in heart failure; improved liver function,” Korner said, “that’s, to me, the exciting part.”

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