With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins

By Meg Tirrell, CNN

(CNN) — The US Food and Drug Administration on Monday approved a daily pill version of Novo Nordisk’s weight-loss drug Wegovy, introducing a new option for how patients can take medicines in a class of drugs that has revolutionized obesity treatment.

The drug, which Novo Nordisk calls simply the Wegovy pill, uses the same active ingredient – semaglutide – that powers the original Wegovy, along with its sister drug for diabetes, Ozempic.

Both Wegovy and Ozempic, which mimic the hormone GLP-1, are given as weekly injections, as are rival drugs from Eli Lilly, called Zepbound and Mounjaro. Altogether, about 1 in 8 US adults say they’re currently taking one of the medicines, according to data from health policy research group KFF.

The Wegovy pill showed roughly similar weight loss and side effects in clinical trials as the Wegovy shot, and will be available by prescription in the US in January, according to Novo Nordisk.

“We believe it will expand access and options for patients,” Dr. Jason Brett, principal US medical head for Novo Nordisk, told CNN in an interview. “We know there are some patients who just won’t take an injectable medication.”

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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