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A weight-loss pill will enter the United States market soon. The Food and Drug Administration (FDA) has green-lit a pill version of Novo Nordisk’s blockbuster weight-loss drug Wegovy.
The medication, known as the Wegovy pill, is the first oral version of a GLP-1 drug that will hit the market for weight loss. Novo Nordisk is planning to launch the pill in early January in the US.
Let’s take a closer look.
US FDA approves Wegovy pill
The US FDA on Monday (December 22) approved the Wegovy pill, which will have to be taken daily on an empty stomach with a small amount of water.
Patients will be advised not to eat, drink or take other medicines for 30 minutes after taking the weight-loss drug.
The pill has the same active ingredient – semaglutide – as the weight loss jab Wegovy and its sister drug for diabetes, Ozempic.
Semaglutide suppresses appetite and has long been used to treat diabetes. In recent years, the drug has been prescribed as a weight-loss medication after research revealed its effectiveness in helping people lose weight.
Wegovy and Ozempic, both of which mimic the hormone GLP-1, are administered as weekly injections. Glucagon-like peptide-1 or GLP-1 is an intestinal hormone released after eating, which usually makes people feel fuller.
Danish drugmaker Novo Nordisk also makes a pill version of semaglutide, called Rybelsus, for diabetes.
The initial, lowest dose of the Wegovy pill will cost $149 (Rs 13,344) for those who pay out of pocket. People usually begin with the lowest dose and gradually increase over several weeks to adjust to any side effects.
The Wegovy pill will be available in doses of 1.5 milligrams, four milligrams, nine milligrams and the likely longer-term dose of 25 milligrams, Dr Jason Brett, principal US medical head for Novo Nordisk, told CNN in an interview.
Weekly injections such as Wegovy and Eli Lilly’s Zepbound have dominated the anti-obesity market so far. However, some people shy away from the shots due to fear of needles or because of cost issues, as per The Wall Street Journal (WSJ).
Pills could also be priced lower and offer better health-insurance coverage than injections, as they cost less to make.
“This is a meaningful step forward in the field,” Dr Christopher McGowan, a gastroenterologist who has a weight loss clinic in Cary, North Carolina, told NBC News. “It won’t replace injectables, but it broadens our tool kit in an important way.”
“Pills are familiar, nonintimidating and fit more naturally into most people’s routines,” McGowan added. “For many patients, a pill isn’t just easier, it’s psychologically more acceptable.”
How effective is the Wegovy pill?
According to the Phase 3 clinical trial results published in the New England Journal of Medicine, participants who took the highest dose of the Wegovy pill experienced a 16.6 per cent weight loss, on average, after 64 weeks.
Weight loss reported in the placebo group during this period was 2.2 per cent.
This is similar to the injectable version of Wegovy, which in clinical trials showed a loss of about 15 per cent body weight after 68 weeks.
Gastrointestinal issues such as nausea and vomiting are the most common reported side effects of GLP-1 drugs.
In some cases, the side effects from the pill version may feel “more intense,” McGowan said, as the drug hits the stomach all at once and can trigger nausea.
“The challenges we see with injectable GLP-1s don’t magically disappear with a tablet,” he said.
Overall, about seven per cent of participants in the Wegovy pill trial stopped taking the drug because of side effects, compared to six per cent on placebo.
As per NBC News, the effectiveness of the Wegovy pill was closer to Eli Lilly’s oral GLP-1 drug, orforglipron, which helped in a weight loss of about 10.5 per cent after 72 weeks in a late-stage trial.
The FDA also approved the Wegovy pill to reduce the risk of heart attacks and strokes in those with cardiovascular disease. The Wegovy shot is also approved for this use.
“We now have injectable-like efficacy in a once-daily pill,” David Moore, executive vice president of Novo Nordisk’s US operations, said. “And that’s a change from where we’ve been in terms of treating obesity.”
Eli Lilly may roll out weight-loss pill in 2026
US pharmaceutical company Eli Lilly’s weight-loss pill could be approved in the coming months. The FDA could clear Lilly’s orforglipron by summer.
The company said its pill was taken during clinical trials once a day at any time, with no restrictions on food or water.
Speaking to CNN, Evan Seigerman, a financial analyst, said this convenience factor could give an edge to Lilly’s pill.
Lilly plans to submit its pill for regulatory approval by the end of 2025.
As per Reuters, the GLP-1 industry could reach $150 billion by 2030. Of this, Leerink Partners analyst David Risinger estimated that pills will eventually account for about 25 per cent of the market.
TD Cowen analysts predicted that the Wegovy pill is likely to generate sales of nearly $2 billion in 2030, while orforglipron will bring about revenue of about $5.6 billion by that time.
With inputs from agencies
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