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Ozempic maker unveils new weight loss pill TWICE as good as its blockbuster jab

Quote:

Ozempic maker unveils new weight loss pill TWICE as good as its blockbuster jab - sending company's value rocketing above Tesla's
[listNovo Nordisk now worth over $566BN, more than Tesla and Visa's valuations[*] Drug led to a 13 percent drop in body weight over 12 weeks, better than Wegovy[/list]

A new weight-loss pill made by the maker of Ozempic sheds weight twice as fast as the blockbuster injections, the company announced.

In a trial of the new drug, called amyretin, patients lost 13 percent of their body weight over 12 weeks - compared to the 6 percent that Wegovy achieved over the same time period.

The results propelled Novo Nordisk to the ranking of 12th most valuable company with a valuation of $566 billion, surpassing that of Tesla and Visa.

The obesity pill led to more weight loss in the same 12 weeks span as the company's groundbreaking injectable Wegovy

Novo Nordisk shares climbed 8 percent on Thursday in Copenhagen, hitting a record high after revealing early results in a study for an obesity medicine in pill form

Company shares surged more than eight percent in Copenhagen, and its total value now exceeds the entire annual output of Denmark.

The drug trial, which is ongoing and expected to produce a fuller picture next year, was welcome news to investors eager to introduce the next generation of obesity medicine.

The drug is similar to Wegovy and its sister drug Ozempic, originally approved solely to treat type 2 diabetes but is now used off label for obesity.

It targets the same GLP-1 hormone, or glucagon-like peptide-1, a hormone in the brain that regulates appetite and feelings of fullness. In addition, it stimulates another hormone, amylin, which also reduces hunger and slows stomach emptying.

The drug also appeared to be safe and well-tolerated among the 16 people who took it over three months, and whose average weight at the start of the trial was 196 pounds.

The speed at which people shed pounds on amyretin far outstripped the amount of time it took for Wegovy and Ozempic patients to lose that amount in trials, which was 68 weeks.

Participants in the trial shed more than 13 percent of their body weight in just three months, a speed that far outpaces the time it takes for Wegovy to work

Meanwhile, Eli Lilly, the maker of Wegovy and Ozempic competitor Zepbound, saw its company shares decline two percent at the New York market open.

Wegovy maker spent $1BILLION on ads and paid doctors millions

Novo Nordisk has also paid tens of millions of dollars to leading physicians who specialize in obesity and cardiology to promote the drugs, encourage their peers to prescribe them and lobby insurers to cover the costs.

Novo's shares have risen more than three-fold since June 2021 when it launched Wegovy in the United States, last year becoming Europe's most valuable listed company, ahead of LVMH.

The company, dead-set on owning a massive chunk of the obesity medicine market, also said it will continue working on another treatment called CagriSema.

It's a combination therapy that contains semaglutide to target GLP-1, as well as a drug called cagrilintide, an analog of the hunger-busting compound amylin.

The combination treatment previously showed 17.1 percent weight loss in over just 20 weeks in a phase 1 obesity trial, compared to 9.8 percent for semaglutide alone.

Marcus Schindler, Novo’s chief of research and early development, told Bloomberg: 'This is a very competitive profile.'

The advent of a highly effective daily pill alternative to the shots will likely alleviate the supply chain issues and delays in getting the medicines into the hands of patients.

The company made an $11 billion deal last month to buy three factories where Wegovy and Ozempic will be produced.

The company also announced it would invest $8.7 billion last year to expand manufacturing capacity for its drugs.

https://www.dailymail.co.uk/health/...ing-Teslas.html

Oh great. Muscle loss will be faster, more damaging, more fragility and bone loss, earlier in life. What could possibly go wrong losing 13% of your body weight in 3 months? :exclm:

I doubt most victims... ahem... I mean patients taking the super-fast weight loss drug will care all that much about muscle loss - at least not until they realize they're losing strength, and if someone points out to them that the heart is a muscle.

It'll be the hair loss that is alarming to them.

But hey, they'll be thinner! And that's the only important thing, right?

Because it's all about BMI, that's the goal, to have a normal BMI absolutely as soon as possible, no matter the cost!

...and the trial was only 16 people. Maybe subject 17 would have died from complications of gastroparesis or something. I'm getting ready for work, so I don't have time to dig, but I wonder what their definition of "well-tolerated" is. Sounds rather subjective. "Yes, the only side effects were (mile long list of non-life-threatening but annoying life-complicating side effects such as inconvenient barfing)

All over the news this morning! Only a Phase 1 trial, but in pill form, and another combo drug is in the works…they are losing their minds with excitement. " “This is going to get big. This is going to get very, very big,” said Maziar Mike Doustdar, head of international operations. "
WSJ story is not behind paywall:

EDITED, sharable: https://www.wsj.com/health/pharma/o...share_permalink

Every news outlet has one, but only the Daily Mail reported:

Quote:

Wegovy maker spent $1BILLION on ads and paid doctors millions Novo Nordisk has also paid tens of millions of dollars to leading physicians who specialize in obesity and cardiology to promote the drugs, encourage their peers to prescribe them and lobby insurers to cover the costs.

The Sackler Empire of Pain playbook.

Quote:

Originally Posted by JEY100

It’s all about greed and nothing about health!

If the trial was only 16 people, it makes me wonder how many people started the trial and dropped out before the trial concluded, and were therefore ignored in the results.

How many people volunteered for the trial, but were rejected due to having pre-existing conditions that might hamper the effectiveness of the drug?

Were the 16 participants hand picked because they had only recently gained weight?

Had any of them tried Wegovy/Zepbound and not done well on them?

Did they purposely choose participants who have very strong stomachs (rarely if EVER throwing up for any reason over the last 10 years)?

Did they choose those who had high BMI's but very little actual FAT to lose? (for instance weight lifters/athletic types who were technically obese by BMI, but had very little excess body fat)

Surely they were able to find more than 16 people who were willing to try a new weight loss drug - they could have probably come up with at least 10 times that many at almost any general practice in the US.

Quote:

Originally Posted by JEY100

All over the news this morning! Only a Phase 1 trial, but in pill form, and another combo drug is in the works…they are losing their minds with excitement. " “This is going to get big. This is going to get very, very big,” said Maziar Mike Doustdar, head of international operations. "
WSJ story is not behind paywall:

https://www.wsj.com/health/pharma/o...e_copyURL_share

Every news outlet has one, but only the Daily Mail reported:

The Sackler Empire of Pain playbook.

I tried to bring up the WSJ article - it says it requires a subscription.

WSJ doesn't make it easy, try this:
Novo Nordisk Shares Surge After Early Trial Shows New Obesity Drug Could Outperform Wegovy
https://www.wsj.com/health/pharma/o...share_permalink

Also, in related, unsurprising news, Oprah will have a TV special about the drugs.

“An Oprah Special: Shame, Blame and the Weight Loss Revolution” will air Monday, March 18 at 8 PM ET on ABC and premiere on Hulu the following day.

https://www.msn.com/en-us/health/ot...-me/ar-BB1jw8du

This was a Phase 1 study. Phase 1 is just the first step and the FDA says:

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Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months

Purpose: Safety and dosage

During Phase 1 studies, researchers test a new drug in normal volunteers (healthy people). In most cases, 20 to 80 healthy volunteers or people with the disease/condition participate in Phase 1. However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer.

Phase 1 studies are closely monitored and gather information about how a drug interacts with the human body. Researchers adjust dosing schemes based on animal data to find out how much of a drug the body can tolerate and what its acute side effects are.

As a Phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increased dosage, and early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits. This is important to the design of Phase 2 studies.

Quote:

Originally Posted by Dodger

This was a Phase 1 study. Phase 1 is just the first step and the FDA says:

I’m not in the habit of gambling, but for this “trial” I would never bet against ultimate FDA approval. Adverse events during trials are the property of the drug company and legally, disclosure by the company is not required. As for the insidious facts that many of us are aware of for these drugs/ poisons that cause weight loss and muscle wasting, I’m betting the trial will never last long enough to document or reveal the most serious adverse events.

This article and others mention…

Quote:

We believe this data release is the primary driver for the shares,” Barclays analysts said in a note. “Importantly, the company noted that it has not ruled out going [straight] into Phase 3 development.”

Shortening or skipping Phase 2 is already baked into expectations.

And breaking news keeps coming…
FDA approves weight-loss drug Wegovy to reduce heart-disease risks

Quote:

The U.S. Food and Drug administration approved the weight-loss drug Wegovy as a treatment to reduce cardiovascular risk in adults who are overweight, the first approval of its kind that could dramatically expand the already huge market for the drug.
Wegovy, which has the same active ingredient as diabetes drug Ozempic, already had FDA approval to treat patients who are obese or overweight. It has become a cultural sensation and a blockbuster, bringing in billions of dollars in revenue for its manufacturer, Novo Nordisk.
“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” John Sharretts, M.D., director in FDA’s Center for Drug Evaluation and Research, said in a statement Friday….

Quote:

Originally Posted by JEY100

“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,”

This is not a move to benefit patients, it's clearly meant to pave the way for insurance companies to pay for its use.

:rolleyes:

FDA press release: https://www.fda.gov/news-events/pre...ults-obesity-or
Full list of warnings and side effects.

It received a priority review for CVD: https://www.fda.gov/patients/fast-t...priority-review

And the biggest US insurance company of all,
AP News: this "opens the door to more people on Medicare"
https://apnews.com/article/ccbc1fc4...6596d5f7bbd6876