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We’re inching nearer to having the first-ever needle-free weight reduction drug.
That’s because of Novo Nordisk, which expects a U.S. approval for its day by day pill for persistent weight administration by the tip of this yr. The firm expects to launch it in early 2026.
The drug is the 25-milligram oral model of semaglutide, the energetic ingredient within the Danish drugmaker’s widespread weight reduction injection Wegovy and diabetes counterpart Ozempic.
Several drugmakers, together with Novo Nordisk’s chief rival Eli Lilly, have been racing to develop obesity pills, which can assist alleviate the availability shortfalls and points accessing the injections available on the market. Pills are seemingly simpler to fabricate than injections, and a few well being specialists hope they could possibly be cheaper.
It could also be too quickly to say which pill will win the best share of the market. But one factor is obvious: Novo Nordisk’s drug may have a head begin.
Novo Nordisk’s Executive Vice President of Research and Development and Chief Scientific Officer, Martin Holst Lange, sat down with CNBC to preview the corporate’s pill.
On the benefits of the pill:
Lange touted the pill’s “unsurpassed” weight reduction, security and tolerability profile.
The pill helped sufferers lose as much as 16.6% of their weight on common at 64 weeks, in accordance with results from a late-stage trial introduced at a medical convention in 2024. That weight reduction was 13.6% when the corporate analyzed all sufferers no matter whether or not they stopped the drug.
The weight reduction seems to be in step with the injectable model of semaglutide (Wegovy), and barely larger than that attributable to an experimental pill from Eli Lilly in a separate part three trial.
“I think the data speaks a little bit for themselves,” Lange stated.
Lange later stated a few of the firm’s opponents count on their tablets to be much less efficient than their injectable medication, however “that’s clearly not the case” for Novo Nordisk.
He additionally pointed to the “substantially lower” charges of sufferers who discontinued the remedy resulting from unwanted side effects, when in comparison with competing medication. But Lange stated to take comparisons “with a grain of salt” since no head-to-head trials straight pit Novo Nordisk’s pill in opposition to different medication.
About 6.9% of sufferers discontinued oral semaglutide resulting from unwanted side effects, which have been primarily gastrointestinal, in comparison with round 5.9% of those that took a placebo.
Meanwhile, 10.3% of sufferers who took the best dose of Eli Lilly’s pill stopped remedy resulting from unwanted side effects, in contrast with round 2.6% of individuals in a placebo group.
Lange additionally stated Novo Nordisk’s pill might have a cardiovascular well being profit. That’s as a result of semaglutide – notably Wegovy – is the one injection available on the market with a longtime and permitted cardiovascular profit.
Novo Nordisk final week stated Wegovy cut the risk of heart attack, stroke or death by 57% versus Eli Lilly’s weight reduction injection Zepbound in a real-world comparability of the rival medicines in sufferers with obesity and cardiovascular illnesses however not diabetes.
In a separate part three trial referred to as “SOUL,” Novo Nordisk’s oral semaglutide lowered the risk of cardiovascular-related death, coronary heart assault and stroke by 14% in comparison with a placebo after 4 years on common in sufferers with diabetes and established coronary heart illness, with or with out persistent kidney illness.
On the pill’s dietary necessities:
Novo Nordisk’s pill is a peptide medicine, whereas opponents like Eli Lilly’s remedy are small-molecule medication.
That means sufferers have to take Novo Nordisk’s oral semaglutide within the morning on an empty abdomen with not more than 4 ounces of plain water. They’re instructed to attend half-hour earlier than consuming, ingesting or taking different oral medicines. Some analysts previously told CNBC that these dietary necessities could possibly be a hurdle for sure sufferers.
But Lange referred to as that “a theoretical concern” and pointed to proof exhibiting that it’s “not a true limitation.” For instance, he stated sufferers have been handled with the pill for as much as 5 years within the placebo-controlled SOUL trial and “even in that setting, we did not see this as a limitation.”
“Patients take that drug apparently without this limiting their life,” Lange stated. “I think that’s a matter of, you get up in the morning, you take the tablet, then typically you take a shower, you go to breakfast and then, very quickly, half an hour is gone.”
On how tablets will match within the obesity market:
Lange stated injections do not seem like “a major obstacle” to individuals taking obesity remedies, however acknowledged that there are some sufferers who do not like needles or produce other causes for not wanting an injectable drug.
Novo Nordisk needs to have the ability to attain these individuals.
“If there’s a big group of people who prefers an oral over an injectable, we want to deliver that,” he stated. “We prefer to deliver that, again, with the same efficacy and safety profile.”
He stated he may also envision sufferers beginning on an injectable and switching to a different type of remedy to take care of their outcomes: “You could switch to an oral, you could switch to a lower dose, you something that gives fewer [gastrointestinal side effects].”
Lange stated that means to transition to totally different remedies needs to be confirmed in a part three trial, however “based on what we’ve seen so far, that is that optionality in our portfolio.”
He highlighted different oral and injectable medication in Novo Nordisk’s pipeline, together with amycretin. That remedy targets the identical intestine hormone that Wegovy mimics, often known as GLP-1, in addition to a pancreas hormone referred to as amylin that impacts starvation. Late-stage trials on amycretin will start subsequent yr, Lange stated.
On assembly demand with provide:
Over the previous few years, injections from Novo Nordisk and Eli Lilly slipped into provide shortages resulting from skyrocketing demand. Those remedies are now not briefly provide, and Wall Street and the well being and medical group hope that tablets will not encounter the identical subject.
Lange stated producing sufficient of the drug to satisfy demand is “obviously key to us,” as Novo Nordisk needs to make sure that sufferers can proceed their remedy. He stated the corporate is assured in with the ability to scale up manufacturing of the remedy.
Lange pointed to the corporate’s investments in growing manufacturing capability over the past a number of years. That features a new manufacturing plant in North Carolina, and a deal to buy three Catalent manufacturing sites from Novo Nordisk’s father or mother firm, Novo Holdings.
Lange stated these investments will assist with the availability of injectables, however “it certainly also goes to the oral active ingredients that are actually being produced in the U.S.”
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OpenAI is doubling down on well being care innovation.
In a post on LinkedIn Tuesday, OpenAI’s Chief Product Officer Kevin Weil introduced he’s creating a brand new initiative throughout the firm referred to as “OpenAI for Science.” The synthetic intelligence firm will rent a small crew of lecturers to construct “an AI-powered platform that accelerates scientific discovery,” Weil stated.
“Paired with a small team of researchers, we want to prove that AI models are ready to accelerate fundamental science—and accelerate research all over the world,” Weil wrote.
OpenAI for Science is not going to completely work on well being care, however Weil shared a number of examples of how AI has been used to speed up health-related and organic analysis in latest months. He talked about Google DeepMind’s AlphaFold, which predicts the construction that proteins fold into, in addition to OpenAI’s work with Retro Biosciences, amongst different examples.
“Scientific discovery improves everything from the quality of our daily lives to national security to global GDP,” Weil stated within the submit. “Innovation is the reason the US leads the world. Few domains hold as much promise for improving lives as science.”
The new scientific initiative comes after OpenAI touted GPT-5 because the “best model yet” for health-related queries. GPT-5, which rolled out final month, is OpenAI’s newest and most superior large-scale AI mannequin.
OpenAI CEO Sam Altman stated a post on X health-related questions are one of many largest classes of utilization for its ChatGPT chatbot.
GPT-5 is designed to proactively flag well being issues, ask related questions and generate extra exact and dependable responses, OpenAI stated in a blog post. Altman stated in his X submit that he hopes GPT-5′s well being capabilities will “provide real service to people.”
“Health care is maybe the area where there’s the strongest improvement of any category,” Altman instructed CNBC’s “Squawk Box” in an interview final month.
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