US approves Wegovy pill, giving Novo Nordisk an edge in obesity drug competition
Under a deal with the Trump administration in November, Novo Nordisk and Eli Lilly agreed to sell starter doses of their weight‑loss pills, if approved, for $US149 a month. (AP: Evan Vucci)
In short:
US regulators have given the green light to a pill version of the blockbuster weight-loss drug Wegovy.
The approval handed Danish drug-maker Novo Nordisk an edge over rival Eli Lilly in the race to market an obesity pill.
What's next?
The pill version of Wegovy is expected to be available in the US within weeks and to be much less expensive than the injectable version.
US regulators have given the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity.
The US Food and Drug Administration's (FDA) approval handed Danish drug-maker Novo Nordisk an edge over rival Eli Lilly in the race to market an obesity pill.
Lilly's oral drug, orforglipron, is still under review.
Both pills are GLP-1 (glucagon-like peptide) drugs that work like widely used injectables to mimic a natural hormone that controls appetite and feelings of fullness.
In recent years, Novo Nordisk's injectable Wegovy and Lilly's Zepbound have revolutionised obesity treatment globally, including in the US, where 100 million people have the chronic disease.
The Wegovy pills are expected to be available within weeks, company officials said.
Availability of oral pills to treat obesity could expand the booming market for obesity treatments by broadening access and reducing costs, experts said.
The US Food and Drug Administration has approved a pill version of Wegovy, meaning people in America will no longer have to inject the weight-loss drug. (Reuters: Hollie Adams)
About one in eight Americans has used injectable GLP-1 drugs, according to a nonprofit health policy research group.
But many more have trouble affording the costly shots.
"There's an entire demographic that can benefit from the pills," said Fatima Cody Stanford, a Massachusetts General Hospital obesity expert.
"For me, it's not just about who gets it across the finish line first.
"It's about having these options available to patients."
The Novo Nordisk obesity pill contains 25 milligrams of semaglutide, the same ingredient in injectables Wegovy and Ozempic and in Rybelsus, a lower-dose pill used to treat diabetes.
All the GLP-1 drugs, oral or injectable, have similar side effects, including nausea and diarrhoea.
Producing pills is generally cheaper than making drugs delivered via injections, so the cost for the new oral medications could be lower.
The Trump administration earlier this year said officials had worked with drug-makers to negotiate lower prices for the GLP-1 drugs, which can cost upwards of $US1,000 ($1,500) a month.
Under a deal with the Trump administration in November, Novo and Lilly agreed to sell starter doses of their weight‑loss pills, if approved, for $US149 a month to US Medicare and Medicaid patients and cash-paying customers who cannot get insurance coverage for the medications.
Pills or needles?
It is not clear whether daily pills or weekly injections will be preferred by patients.
Although some patients dislike needles, others do not seem to mind the weekly injections, obesity experts said.
Angela Fitch, an obesity expert and chief medical officer of health care company knownwell, said whatever the format, the biggest benefit will be in making weight-loss medications more widely accessible and affordable.
"It's all about the price," Dr Fitch said.
"Just give me a drug at $100 a month that is relatively effective."
Unlike Australia, where many drugs are listed on the Pharmaceutical Benefits Scheme and subsidised by the federal government, in the US, drug pricing is managed through health insurance plans.
A key part of making the pills a success will be attracting cash-paying consumers, a stark shift.
David Moore, a US Novo executive, said they would have a self-pay offer "from day one for US patients".
Novo plans to launch the Wegovy pill on multiple channels — including retail pharmacies, online platforms and telehealth partners — so people can start treatment without waiting for insurance coverage, he said.
The focus on cash-paying consumers aims to revive Novo's slowing sales growth and turbocharge the next stage of expansion for the wider market.
Danish company Novo Nordisk is hoping to capitalise on the lucrative American appetite for weight loss. (Reuters: Tom Little)
Novo has lost hundreds of billions of dollars in market capitalisation since mid-2024 amid rising competition.
"We've never launched this way before," Mr Moore said.
In the past, "the mindset was more traditional — the product is available, you wait for insurers to cover it, and it's at the retail pharmacy," he said.
Novo is facing intensifying competition from Lilly's rival obesity drug Zepbound, known outside the US as Mounjaro, and pressure from cheaper, unapproved compounded versions of semaglutide, the active ingredient in the Wegovy injection and pill.
Lilly is awaiting FDA approval for its weight-loss pill, which could come as early as March.
Novo hopes the once-daily oral dose of Wegovy could be a turning point in attracting people who were not motivated to start treatment with GLP‑1 injections.
Novo's US medical head, Jason Brett, said that the pill could broaden access by giving doctors more choice in what they prescribe, and help "meet patients where they are" via telehealth.
Novo does not expect the pill to cannibalise its injectable Wegovy business.
Analysts and industry executives also do not expect oral GLP-1s to fully replace injections, but say pills could capture 20 per cent of the global obesity drug market by 2030.
"There are people who are needle-phobic, people who develop 'injection fatigue,' and people who don't see themselves as sick and feel an injectable is too serious," said Zachariah Reitano, chief executive of telehealth company Ro.
"For all of them, a pill is a much easier on-ramp."
AP, Reuters