Healthy Returns: A key step forward for Novo Nordisk's GLP-1 pill

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A intimately watched pill from Novo Nordisk conscionable scored an approval for different use: slashing cardiovascular risks.

The measurement further confirms that highly fashionable GLP-1s, some oral and injectable versions, person different wellness benefits beyond regulating humor sweetener and promoting value loss. 

The Food and Drug Administration connected Friday cleared oral semaglutide for lowering the hazard of large cardiovascular complications, specified arsenic bosom attack, changeable oregon cardiovascular decease successful radical with benignant 2 diabetes and who are astatine precocious hazard of experiencing those events. In the late-stage SOUL trial, a 14-milligram dose of the pill reduced the hazard of those complications by 14% astatine 4 years compared to a placebo. 

Oral semaglutide, sold nether the sanction Rybelsus for diabetes, has been connected the marketplace since 2019 and remains the lone approved GLP-1 pill. Semaglutide is besides the progressive constituent successful Novo Nordisk's blockbuster obesity injection Ozempic and obesity attraction Wegovy, the second of which is also approved for bosom health successful radical with obesity and established cardiovascular disease. 

"Having an oral GLP-1 therapy to assistance amended glycemic power was an innovation successful and of itself," said Dr. John Buse, manager of the University of North Carolina School of Medicine Diabetes Care Center and steering committee co-chair of the SOUL trial, successful a statement. "This caller indication, based connected the SOUL data, marks adjacent further advancement and showcases the versatility of semaglutide portion expanding options for millions of people."

But each eyes are connected different FDA determination that is slated to travel by year-end: whether to o.k. oral semaglutide for obesity. Patients utilizing blockbuster value nonaccomplishment drugs are anxious for a much convenient enactment that could easiness the proviso shortfalls and entree hurdles created by the pricey play injections presently dominating it.

Oral semaglutide is slated to beryllium the first-ever GLP-1 pill approved for the attraction of obesity, but a rival from Eli Lilly called orforglipron is not excessively acold down it. In August, Eli Lilly CEO Dave Ricks said the institution hopes to motorboat its pill globally "this clip adjacent year."

Wall Street is watching to spot which pill could triumph much marketplace share, arsenic they some person their ain advantages. For example, successful obesity trials, the efficacy of Eli Lilly's pill appeared to travel successful somewhat beneath that of Novo Nordisk's oral semaglutide. 

But portion Novo Nordisk's pill is simply a peptide medication, orforglipron is simply a small-molecule drug.

That means Eli Lilly's pill is absorbed much easy successful the assemblage and doesn't necessitate dietary restrictions similar Novo Nordisk's does. Some analysts person besides said that orforglipron volition beryllium easier to manufacture astatine scale, which is important arsenic request for obesity and diabetes injections outpaces supply.

Both Novo Nordisk and Eli Lilly are studying their pills successful different areas. Novo Nordisk is examining oral semaglutide successful patients with Alzheimer's disease. Meanwhile, Eli Lilly is studying orforglipron successful abstracted trials successful patients with obstructive slumber apnea and hypertension. 

We'll beryllium watching some pills closely, truthful enactment tuned for our coverage.

Feel escaped to nonstop immoderate tips, suggestions, communicative ideas and information to Annika astatine a caller email: annika.constantino@versantmedia.com.

Mark Cuban says his startup Cost Plus Drugs volition beryllium 1 of the offerings connected TrumpRx erstwhile the Trump administration's caller cause level launches adjacent year. 

While the billionaire entrepreneur said he is inactive not a instrumentality of the president, helium gives him recognition for trying to cut drug prices, and hopes the administration will go even further. Along with direct-to-consumer sales, Cuban hopes the authorities volition require insurers to use currency purchases for drugs toward patients' deductibles.

I got a accidental to beryllium down with Cuban astatine the HLTH league successful Las Vegas connected Sunday for a wide-ranging speech connected cause prices. He co-founded Cost Plus 3 years agone arsenic a changeable crossed the bow astatine pharmacy payment managers, oregon PBMs, and he's inactive railing against the middlemen.  He contends they're "ripping you off" and driving cause costs higher.  

Well, connected Monday 1 of the large PBMs called out Cuban connected his claims. CVS sent maine a information expanse comparing its TrueCost rebate pass-through PBM exemplary for employers with Cost Plus prices. Among the examples, the generic cholesterin cause Atorvastatin costs astir $6 on the CVS plan, and $10 connected Cost Plus.

During a league connected stage, CVS Health Chief Technology Officer Tilak Mandadi told maine that Cuban's claims astir PBMs are "bulls--t," pointing to savings connected generic drugs that the institution offers employers done TrueCost.

He and Chief Medical Officer Dr. Amy Compton-Phillips argued that PBM rebates are not driving increased drug costs, but rather it's the drugmakers who acceptable precocious prices connected specialty and marque sanction drugs.  What's more, they told me, galore of those aforesaid pharmaceutical companies usage CVS' PBM rebate services to try to rein successful costs for their ain employees.

What were the likelihood that things would get spicy successful Vegas? You tin stake that statement volition proceed beyond Sin City. 

Here's an edited mentation of my speech with Mark Cuban.

Novo Nordisk U.S. President Dave Moore confirmed his institution is "right present successful progressive dialogue" with the Trump medication over so-called most favored federation pricing for its fashionable GLP-1 drugs Ozempic and Wegovy.

 Last week, President Donald Trump said he'd similar to get the currency terms of Ozempic down to $150, while Centers for Medicare & Medicaid Administrator Dr. Mehmet Oz noted that thing had been settled yet.

During a sitdown at HLTH, Moore would not supply immoderate specifics connected the pricing discussions with the administration on most-favored federation pricing or the Inflation Reduction Act Medicare terms negotiations, which are conscionable wrapping up this month. But he said the institution wants to enactment with the medication to supply much entree for patients.

 "I deliberation there's immoderate similar mindedness from the president and the medication that we besides privation to marque definite that our medicines are available," Moore said, adding that helium could spot the company's Novocare direct-to-consumer tract being part of TrumpRx.

 "If we tin spouse with that … I deliberation it's a truly positive step forward," helium said.

Novocare Pharmacy, the nonstop income platform that launched earlier this year, currently accounts for astir 11% of the company's Wegovy sales. Rival Eli Lilly's direct-to-consumer tract LillyDirect accounts for 35% of new sales of value nonaccomplishment cause Zepbound.  Having some connected TrumpRx could rise the illustration of the companies' cash income programs adjacent more.

Those discussions are happening conscionable arsenic Novo Nordisk is ramping up its manufacturing facilities successful North Carolina successful anticipation of its Wegovy pill being approved by the FDA.  Moore said the institution is making sure it will beryllium capable to conscionable request erstwhile the clip comes.

Watch my speech with Moore here.

Feel escaped to nonstop immoderate tips, suggestions, communicative ideas and information to Bertha astatine bertha.coombs@versantmedia.com.