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A key step forward for Novo Nordisk’s GLP-1 pill

INBV News by INBV News
October 22, 2025
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A key step forward for Novo Nordisk’s GLP-1 pill
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Novo Nordisk flags flutter outside their office in Bagsvaerd, on the outskirts of Copenhagen, Denmark, July 14, 2025.

Tom Little | Reuters

A version of this text first appeared in CNBC’s Healthy Returns newsletter, which brings the newest health-care news straight to your inbox. Subscribe here to receive future editions.

A closely watched pill from Novo Nordisk just scored an approval for one more use: slashing cardiovascular risks.

The step further confirms that highly popular GLP-1s, each oral and injectable versions, produce other health advantages beyond regulating blood sugar and promoting weight reduction. 

The Food and Drug Administration on Friday cleared oral semaglutide for lowering the chance of major cardiovascular complications, reminiscent of heart attack, stroke or cardiovascular death in individuals with type 2 diabetes and who’re at high risk of experiencing those events. Within the late-stage SOUL trial, a 14-milligram dose of the pill reduced the chance of those complications by 14% at 4 years in comparison with a placebo. 

Oral semaglutide, sold under the name Rybelsus for diabetes, has been in the marketplace since 2019 and stays the one approved GLP-1 pill. Semaglutide can also be the lively ingredient in Novo Nordisk’s blockbuster obesity injection Ozempic and obesity treatment Wegovy, the latter of which can also be approved for heart health in individuals with obesity and established heart problems. 

“Having an oral GLP-1 therapy to assist improve glycemic control was an innovation in and of itself,” said Dr. John Buse, director of the University of North Carolina School of Medicine Diabetes Care Center and steering committee co-chair of the SOUL trial, in an announcement. “This recent indication, based on the SOUL data, marks even further advancement and showcases the flexibility of semaglutide while expanding options for thousands and thousands of individuals.”

But all eyes are on one other FDA decision that’s slated to return by year-end: whether to approve oral semaglutide for obesity. Patients using blockbuster weight reduction drugs are looking forward to a more convenient option that might ease the availability shortfalls and access hurdles created by the pricey weekly injections currently dominating it.

Oral semaglutide is slated to be the first-ever GLP-1 pill approved for the treatment of obesity, but a competitor from Eli Lilly called orforglipron shouldn’t be too far behind it. In August, Eli Lilly CEO Dave Ricks said the corporate hopes to launch its pill globally “this time next 12 months.”

Wall Street is watching to see which pill could win more market share, as they each have their very own benefits. For instance, in obesity trials, the efficacy of Eli Lilly’s pill appeared to are available barely below that of Novo Nordisk’s oral semaglutide. 

But while Novo Nordisk’s pill is a peptide medication, orforglipron is a small-molecule drug.

Meaning Eli Lilly’s pill is absorbed more easily within the body and doesn’t require dietary restrictions like Novo Nordisk’s does. Some analysts have also said that orforglipron might be easier to fabricate at scale, which is crucial as demand for obesity and diabetes injections outpaces supply.

Each 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 each pills closely, so stay tuned for our coverage.

Be happy to send any suggestions, suggestions, story ideas and data to Annika at a brand new email: annika.constantino@versantmedia.com.

Latest in health care: Mark Cuban gives Trump credit on drug prices, trashes PBMs and gets called out by one

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

Julia Beverly | Wireimage | Getty Images

Mark Cuban says his startup Cost Plus Drugs might be one among the offerings on TrumpRx when the Trump administration’s recent drug platform launches next 12 months. 

While the billionaire entrepreneur said he continues to be not a fan of the president, he gives him credit for attempting to cut drug prices, and hopes the administration will go even further. Together with direct-to-consumer sales, Cuban hopes the federal government would require insurers to use money purchases for drugs toward patients’ deductibles.

I got a probability to take a seat down with Cuban on the HLTH conference in Las Vegas on Sunday for a wide-ranging conversation on drug prices. He co-founded Cost Plus three years ago as a shot across the bow at pharmacy profit managers, or PBMs, and he’s still railing against the middlemen.  He contends they’re “ripping you off” and driving drug costs higher.  

Well, on Monday one among the large PBMs called out Cuban on his claims. CVS sent me a fact sheet comparing its TrueCost rebate pass-through PBM model for employers with Cost Plus prices. Among the many examples, the generic cholesterol drug Atorvastatin costs about $6 on the CVS plan, and $10 on Cost Plus.

During a session on stage, CVS Health Chief Technology Officer Tilak Mandadi told me that Cuban’s claims about PBMs are “bulls–t,” pointing to savings on generic drugs that the corporate offers employers through TrueCost.

He and Chief Medical Officer Dr. Amy Compton-Phillips argued that PBM rebates usually are not driving increased drug costs, but reasonably it is the drugmakers who set high prices on specialty and brand name drugs.  What’s more, they told me, a lot of those self same pharmaceutical corporations use CVS’ PBM rebate services to try to rein in costs for their very own employees.

What were the percentages that things would get spicy in Vegas? You’ll be able to bet that debate will proceed beyond Sin City. 

Here’s an edited version of my conversation with Mark Cuban.

Speaking of drug prices, could Novo Nordisk strike the following drug pricing deal?

Novo Nordisk U.S. President Dave Moore confirmed his company is “right away in lively dialogue” with the Trump administration over so-called most favored nation pricing for its popular GLP-1 drugs Ozempic and Wegovy.

 Last week, President Donald Trump said he’d wish to get the money price of Ozempic all the way down to $150, while Centers for Medicare & Medicaid Administrator Dr. Mehmet Oz noted that nothing had been settled yet.

During a sitdown at HLTH, Moore wouldn’t provide any specifics on the pricing discussions with the administration on most-favored nation pricing or the Inflation Reduction Act Medicare price negotiations, that are just wrapping up this month. But he said the corporate desires to work with the administration to offer more access for patients.

 “I believe there’s some like mindedness from the president and the administration that we also need to be sure that that our medicines can be found,” Moore said, adding that he could see the corporate’s Novocare direct-to-consumer site being a part of TrumpRx.

 “If we will partner with that … I believe it’s a extremely positive step forward,” he said.

Novocare Pharmacy, the direct sales platform that launched earlier this 12 months, currently accounts for about 11% of the corporate’s Wegovy sales. Rival Eli Lilly’s direct-to-consumer site LillyDirect accounts for 35% of latest sales of weight reduction drug Zepbound.  Having each on TrumpRx could raise the profile of the businesses’ money sales programs much more.

Those discussions are happening just as Novo Nordisk is ramping up its manufacturing facilities in North Carolina in anticipation of its Wegovy pill being approved by the FDA.  Moore said the corporate is ensuring it will find a way to satisfy demand when the time comes.

Watch my conversation with Moore here.

Be happy to send any suggestions, suggestions, story ideas and data to Bertha at bertha.coombs@versantmedia.com.

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