An necessary advance for Novo Nordisk’s GLP-1 capsule

Novo Nordisk flags fly in front of their office in Bagsvaerd, on the outskirts of Copenhagen, Denmark, July 14, 2025.

Tom Little | Reuters

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A closely watched pill from Novo Nordisk has just received approval for another use: reducing cardiovascular risks.

The move also confirms that the highly popular GLP-1, in both oral and injectable forms, has additional health benefits beyond regulating blood sugar and promoting weight loss.

The Food and Drug Administration on Friday approved oral semaglutide to reduce the risk of serious cardiovascular complications such as heart attack, stroke or cardiovascular death in people with type 2 diabetes who are at high risk of these events. In the late-stage SOUL trial, a 14-milligram dose of the pill reduced the risk of these complications by 14% after four years compared to 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 drug Wegovy, the latter of which is also approved for heart health in people with obesity and existing cardiovascular disease.

“Oral GLP-1 therapy to improve blood sugar control was an innovation in and of itself,” said Dr. John Buse, director of the Diabetes Care Center at the University of North Carolina School of Medicine and co-chair of the SOUL study steering committee, in a statement. “This new indication, based on the SOUL data, represents further progress and demonstrates the versatility of semaglutide while expanding options for millions of people.”

But all eyes are on another FDA decision due by year’s end: whether to approve oral semaglutide for obesity. Patients using blockbuster weight-loss drugs want a more convenient option that could ease the supply shortages and access barriers created by the expensive weekly injections currently prevalent.

Oral semaglutide is said to be the first-ever GLP-1 pill approved for the treatment of obesity, but a competitor to Eli Lilly called Orforglipron is not too far behind. In August, Eli Lilly CEO Dave Ricks said the company hoped to launch its pill globally “by 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 studies, the effectiveness of Eli Lilly’s pill appeared to be slightly less than that of Novo Nordisk’s oral semaglutide.

But while Novo Nordisk’s pill is a peptide drug, Orforglipron is a small molecule drug.

This means that Eli Lilly’s pill is more easily absorbed by the body and does not require dietary restrictions like Novo Nordisk does. Some analysts have also said orforglipron will be easier to produce on a large scale, which is crucial as demand for obesity and diabetes injections outstrips supply.

Both Novo Nordisk and Eli Lilly are exploring their pills in other areas. Novo Nordisk is studying oral semaglutide in patients with Alzheimer’s disease. Meanwhile, Eli Lilly is studying orforglipron in separate trials in patients with obstructive sleep apnea and high blood pressure.

We’ll be watching both pills closely, so stay tuned for our coverage.

Feel free to send tips, suggestions, story ideas and data to Annika at a new email address: annika.constantino@versantmedia.com.

The latest in healthcare: Mark Cuban praises Trump for drug prices, blasts PBMs and gets taken to task by one

Mark Cuban speaks onstage during the 2025 SXSW Conference and Festival at the Hilton Austin on March 10, 2025 in Austin, Texas.

Julia Beverly | Wireimage | Getty Images

Mark Cuban says his startup Cost Plus Drugs will be one of the offerings on TrumpRx when the Trump administration’s new drug platform launches next year.

Although the billionaire entrepreneur said he is still not a fan of the president, he appreciates his attempts to lower drug prices and hopes the administration will go further. Cuban hopes that in addition to direct sales to consumers, the government will require insurers to count cash purchases of drugs toward patients’ deductibles.

I had the opportunity to sit down with Cuban on Sunday at the HLTH conference in Las Vegas for an in-depth conversation about drug pricing. He co-founded Cost Plus three years ago, as a shooter at Pharmacy Benefit Managers (PBMs), and he still rails against the middlemen. He claims they are “cheating” and driving up drug costs.

Well, on Monday one of the major PBMs criticized Cuban for his claims. CVS sent me a fact sheet comparing the TrueCost employer discount pass-through PBM model to Cost Plus pricing. Examples include the generic cholesterol drug atorvastatin, which costs about $6 on the CVS plan and $10 on the Cost Plus plan.

During an onstage session, Tilak Mandadi, CVS Health’s chief technology officer, told me that Cuban’s claims about PBMs were “bullshit,” citing savings on generic drugs the company offers employers through TrueCost.

He and Chief Medical Officer Dr. Amy Compton-Phillips argued that PBM rebates do not lead to higher drug costs, but rather that drug manufacturers are the ones setting high prices for specialty and brand-name drugs. Additionally, they told me, many of these pharmaceutical companies use CVS’s PBM discount services to contain costs for their own employees.

What were the chances of things getting hot in 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 strike the next drug pricing deal?

Dave Moore, U.S. president of Novo Nordisk, confirmed that his company is “currently in active dialogue” with the Trump administration over so-called MFN pricing for its popular GLP-1 drugs Ozempic and Wegovy.

Last week, President Donald Trump said he would like to lower Ozempic’s cash price to $150, while Centers for Medicare & Medicaid Administrator Dr. Mehmet Oz, noted that nothing had been clarified yet.

During a meeting at HLTH, Moore would not provide details about pricing talks with the government over MFN pricing or the Medicare Inflation Reduction Act pricing negotiations that are just wrapping up this month. However, he said the company wants to work with the administration to provide better access for patients.

“I think there’s a shared sentiment among the president and the administration that we also want to make sure our medications are available,” Moore said, adding that he could envision the company’s Novocare direct-to-consumer side being part of TrumpRx.

“If we can work together on that … I think that’s a really positive step forward,” he said.

Novocare Pharmacy, the direct-to-consumer platform launched earlier this year, currently accounts for about 11% of the company’s Wegovy sales. Rival Eli Lilly’s direct-to-consumer website LillyDirect accounts for 35% of new sales of weight-loss drug Zepbound. Having both on TrumpRx could raise the profile of the companies’ cash sales programs even further.

These discussions are taking place as Novo Nordisk ramps up its manufacturing facilities in North Carolina in anticipation of FDA approval of its Wegovy pill. Moore said the company is ensuring it is able to meet demand when the time comes.

Watch my conversation with Moore here.

You can always send tips, suggestions, story ideas and data to Bertha at bertha.coombs@versantmedia.com.