Novo Nordisk flags fly in front of its office in Bagsvaerd, outside Copenhagen, Denmark, on July 14, 2025.
Little Tom | Reuters
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A pill closely watched by Nordisk just gained approval for another use: dramatically reducing cardiovascular risks.
The move further confirms that the highly popular GLP-1, both in its oral and injectable versions, has other health benefits beyond regulating blood sugar and promoting weight loss.
On Friday, the Food and Drug Administration approved oral semaglutide to reduce the risk of major cardiovascular complications, such as heart attacks, strokes or cardiovascular death in people with type 2 diabetes and who are at high risk of experiencing such events. In the late-stage SOUL trial, a 14-milligram dose of the pill reduced the risk of those complications by 14% at four years compared with a placebo.
Oral semaglutide, sold under the name Rybelsus for diabetes, has been on the market since 2019 and remains the only approved GLP-1 pill. Semaglutide is also the active ingredient in Novo Nordisk's blockbuster obesity injection Ozempic and obesity treatment Wegovy, the latter of which is also approved for heart health in people with obesity and established cardiovascular disease.
“Having oral GLP-1 therapy to help improve glycemic control was a breakthrough in itself,” Dr. John Buse, director of the Center for Diabetes Care at the University of North Carolina School of Medicine and co-chair of the SOUL trial steering committee, said in a statement. “This new indication, based on SOUL data, marks an even greater advance and shows the versatility of semaglutide while expanding options for millions of people.”
But all eyes are on another FDA decision expected by the end of the year: whether to approve oral semaglutide for obesity. Patients using blockbuster weight-loss medications are eager for a more convenient option that can alleviate supply shortages and access barriers created by the expensive weekly injections that currently dominate.
Oral semaglutide is planned to be the first GLP-1 pill approved for the treatment of obesity, but a competitor to Eli Lilly called orforglipron is not far behind. In August, Eli Lilly CEO Dave Ricks said the company hopes to launch its pill globally “this time next year.”
Wall Street is watching to see which pill could gain more market share, as both have their own advantages. For example, in obesity trials, the effectiveness of Eli Lilly's pill appeared to be slightly lower than that of Novo Nordisk's oral semaglutide.
But while Novo Nordisk pill is a peptide drug, forglipron is a small molecule drug.
That means Eli Lilly's pill is more easily absorbed into the body and doesn't require dietary restrictions like Novo Nordisk's. Some analysts have also said that orforglipron will be easier to manufacture at scale, which is crucial as demand for obesity and diabetes shots outstrips supply.
Both Novo Nordisk and Eli Lilly are studying their pills in other areas. Novo Nordisk is examining oral semaglutide in patients with Alzheimer's disease. Meanwhile, Eli Lilly is studying orforglipron in separate trials in patients with obstructive sleep apnea and hypertension.
We'll be watching both pills closely, so stay tuned for our coverage.
Feel free to send any tips, suggestions, story ideas and facts to Annika at a new email: [email protected].
The latest in healthcare: Mark Cuban credits Trump for drug prices, trashes PBMs, and one criticizes him
Mark Cuban speaks on stage during the SXSW 2025 Conference and Festival at the Hilton Austin on March 10, 2025 in Austin, Texas.
Julia Beverly | Wire image | fake images
Mark Cuban says his startup Cost Plus Drugs will be one of TrumpRx's offerings when the Trump administration's new drug platform launches next year.
While the billionaire businessman said he is not yet a fan of the president, he credits him for trying to lower drug prices and hopes the administration will go even further. In addition to direct-to-consumer sales, Cuban hopes the government will require insurers to apply cash drug purchases to patients' deductibles.
I had the opportunity to sit down with Cuban at the HLTH conference in Las Vegas on Sunday for a wide-ranging conversation about drug prices. He co-founded Cost Plus three years ago as a swipe at pharmacy benefit managers, or PBMs, and is still criticizing middlemen. He maintains that he is being “ripped off” and driving up drug costs.
Well, on Monday one of the big PBMs criticized Cuban for his claims. CVS sent me a fact sheet comparing their TrueCost Reimbursement Transfer PBM model for employers to Cost Plus pricing. Among examples, the generic cholesterol drug Atorvastatin costs about $6 on the CVS plan and $10 on Cost Plus.
During an onstage session, Tilak Mandadi, CVS Health's chief technology officer, told me that Cuban's claims about PBMs are “nonsense,” pointing to the savings on generic drugs the company offers employers through TrueCost.
He and Chief Medical Officer Dr. Amy Compton-Phillips argued that PBM rebates are not driving rising drug costs, but instead drug manufacturers are setting high prices for specialty and brand-name drugs. What's more, I'm told, many of those same drug companies use CVS's PBM reimbursement services to try to control costs for their own employees.
What were the chances of things getting spicy in Las Vegas? You can bet the debate will continue beyond Sin City.
Here is an edited version of my conversation with Mark Cuban.
Speaking of drug pricing, could Novo Nordisk close the next drug pricing deal?
Novo Nordisk's US president, Dave Moore, confirmed that his company is “currently in active dialogue” with the Trump administration over the so-called most favored nation price for its popular GLP-1 drugs Ozempic and Wegovy.
Last week, President Donald Trump said he would like to reduce Ozempic's cash price to $150, while Dr. Mehmet Oz, administrator of the Centers for Medicare and Medicaid, said nothing had been agreed upon yet.
During a meeting at HLTH, Moore did not provide any details about pricing discussions with the administration over most-favored nation pricing or the Inflation Reduction Act Medicare pricing negotiations, which are just wrapping up this month. But he said the company wants to work with the administration to provide more access to patients.
“I think there's a similar mindset on the part of the president and the administration that we also want to make sure our medications are available,” Moore said, adding that he could see the company's Novocare direct-to-consumer site being part of TrumpRx.
“If we can partner with that… I think it's a really positive step forward,” he said.
Novocare Pharmacy, the direct sales platform that launched earlier this year, currently accounts for around 11% of the company's Wegovy sales. Rival Eli Lilly's direct-to-consumer site, LillyDirect, accounts for 35% of new sales of the weight-loss drug Zepbound. Having both on TrumpRx could further raise the profile of the companies' cash sales programs.
Those discussions come just as Novo Nordisk is expanding its manufacturing facility in North Carolina in anticipation of the FDA approving its Wegovy pill. Moore said the company is making sure it can meet demand when the time comes.
Watch my conversation with Moore here.
Please feel free to send any tips, suggestions, story ideas or information to Bertha at [email protected].
