In a significant development for obesity treatment, the US Food and Drug Administration has granted approval for a daily pill version of Novo Nordisk’s weight-loss medication, Wegovy. This new oral option marks a notable addition to the arsenal of treatments that have been transforming the way obesity is managed.
The newly approved Wegovy pill utilizes semaglutide, the same active ingredient found in the injectable form of Wegovy, as well as Novo Nordisk’s diabetes medication, Ozempic. These drugs work by mimicking the hormone GLP-1, which plays a crucial role in regulating appetite and glucose levels.
Previously, patients using Wegovy and its counterpart Ozempic had to rely on weekly injections. Similar injectable treatments are available from Eli Lilly, such as Zepbound and Mounjaro. According to data from the health policy research group KFF, roughly one in eight American adults are currently using one of these medications.
Clinical trials for the Wegovy pill revealed weight loss results and side effects comparable to the injectable version. This new oral form will be accessible by prescription in the United States starting January, as reported by Novo Nordisk.
“This innovation is expected to broaden access and provide more choices for patients,” said Dr. Jason Brett, principal US medical head for Novo Nordisk, in a conversation with CNN. “We understand that some individuals are reluctant to use injectable medications.”
The initial out-of-pocket cost for the Wegovy pill will be $149, as per an arrangement disclosed in November with the Trump administration. While the price may rise as the dosage increases, specific figures have not been released. Patients with insurance coverage for the medication are likely to benefit from reduced copayments.
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.”
