FDA approves once-weekly 2.4mg semaglutide for chronic weight management

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Eddy Edson

Eddy Edson

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Relationship to Diabetes
Type 2
www.novonordisk.com

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www.novonordisk.com www.novonordisk.com

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Wegovy™ (the brand name for once-weekly semaglutide 2.4 mg injection in the US) for chronic weight management. Wegovy™ is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity (initial BMI≥30 kg/m2) or overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity.

Wegovy™ is the first and only once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management for people living with obesity. The approval is based on the results from the STEP phase 3a clinical trial programme. Across the trials in people without type 2 diabetes, an average weight loss of 17-18%1 sustained over 68 weeks was reported for people with obesity treated with Wegovy™. Wegovy™ demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal.

“The approval of Wegovy™ in the US brings great promise to people with obesity. Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favour weight regain,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “The unprecedented weight loss for an anti-obesity medication marks a new era in the treatment of obesity, and we now look forward to making Wegovy™ available to people living with obesity in the US”.

Novo Nordisk expects to launch WegovyTM in the United States later in June 2021.


Wegovy?? Maybe it doesn't sound so ridiculous in Danish ... Apart from that, med therapies like these are surely the biggest key to dealing with the "Obesity Crisis".
 
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This pill doesn't deal with the underlying causes of obesity so for the life of me, I can't believe that this can be the solution.
 
pm133 said:
This pill doesn't deal with the underlying causes of obesity so for the life of me, I can't believe that this can be the solution.
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It’s an injection that reduces hunger hormones so you don’t feel as starving hungry all the time, which can be a cause of obesity. Some with t2 don’t produce enough of the feeling full hormones which causes them to eat too much.
 
Lucyr said:
It’s an injection that reduces hunger hormones so you don’t feel as starving hungry all the time, which can be a cause of obesity. Some with t2 don’t produce enough of the feeling full hormones which causes them to eat too much.
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I know how it works.

It's interesting how this "hunger hormone" problem leaves us starving hungry for pies, cakes and chocolate but not fresh meat, fruit or veg. It's also interesting that not all Western countries have the obesity crisis we are facing. Are we uniquely blighted in having this hormone problem? Maybe, but it doesn't sound very likely.

For these reasons, I'm just sceptical about the validity of this ytpe of thing from a scientific point of view. Things like this are dealing with symptoms of obesity and not root causes in my opinion.

The root cause of the bulk of obesity is over-eating. It's not possible to get obese any other way. And the root cause of over-eating is largely rooted in psychology. I suspect that there's just no getting away from that if we want to solve the problem properly.
 
It's the eating of highly processed food. That of itself suppresses the the "feeling full" hormone, but nobody really knows why. That causes the desire for even more highly processed food. And in the US highly processed food is even more ubiquitous, as well as portion sizes being bigger.

As you say,@pm133, the problem is overeating. It's not really psychology, it's more like an addiction for highly processed food.
 
mikeyB said:
It's the eating of highly processed food. That of itself suppresses the the "feeling full" hormone, but nobody really knows why. That causes the desire for even more highly processed food. And in the US highly processed food is even more ubiquitous, as well as portion sizes being bigger.

As you say,@pm133, the problem is overeating. It's not really psychology, it's more like an addiction for highly processed food.
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What I meant was that the battle to fix this is, like all addictions, a psychological one.
It's asking people to move from something they consider tasty and convenient to something they perceive is neither. Obesity is a behavioural problem in that sense.

It's a very hard sell which is why virtually all diets fail - they don't deal with the fundamental issue behind binge eating.

I understand the point about "hunger hormones" but honestly I'm a bit wary of using that phrase because there's a very real risk that people start blaming the food and using that excuse as a crutch to do nothing to solve their problem.

I don't want to underplay the magnitude of the difficulty faced by anyone losing weight though. I know it's really difficult from personal experience. That's just stage 1.
Keeping the weight off is stage 2.
 
@mikeyB. How do you define "highly processed".
 
Yes but one nobody asks. You might argue that there is little more highly processed than beef steak. An enormous number of processes are needed to make it from dirt and water. Even turning the same dirt and water into a humble lettuce leaf is pretty complicated, involving many more processes than those used in making food products for sale.
 
Docb said:
@mikeyB. How do you define "highly processed".
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By highly processed (which is a widely accepted term in nutrition) it's the techniques and additives that make, say, a burger have a longer shelf life, or ready made meals. It's the stuff they put in bread to lengthen shelf life. It's the excess of sugar where it doesn't belong. You see it in the lists of ingredients in, for example, Pot noodles. None of this stuff adds nutrition, it just adds more profit to the manufacturers.

And you know as well as I do, @Docb, that equating all that to natural biological processes is a nonsense.
 
mikeyB said:
By highly processed (which is a widely accepted term in nutrition) it's the techniques and additives that make, say, a burger have a longer shelf life, or ready made meals. It's the stuff they put in bread to lengthen shelf life. It's the excess of sugar where it doesn't belong. You see it in the lists of ingredients in, for example, Pot noodles. None of this stuff adds nutrition, it just adds more profit to the manufacturers.

And you know as well as I do, @Docb, that equating all that to natural biological processes is a nonsense.
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I have a burger press.
I would say ground steak, with a bit of seasoning pressed just before I cook them is more addictive than a Birds Eye frozen burger, with additives for a longer shelf life.
I made some with a plant based mince yesterday, while they were good, I wouldn't rush back for more mince.
And again, while I do eat pot noodles, I prefer a home made noodle dish.
I can't think of any food I couldn't recreate better, I don't think processing adds a great flavour, or has an ability to suppress hormones. I can overeat on my own food probably more.
 
It's all a question of cost, @travellor. Most folk who are living on Universal Credit don't have the time or money to make their own burgers from ground steak, or buy sausages without 30% filler. And yes, Pot noodles as well.

I bet you don't make your own noodles. I do.😉
 
mikeyB said:
It's all a question of cost, @travellor. Most folk who are living on Universal Credit don't have the time or money to make their own burgers from ground steak, or buy sausages without 30% filler. And yes, Pot noodles as well.

I bet you don't make your own noodles. I do.😉
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That's not an addiction.
It certainly won't supress the hunger hormone.
I agree it might be more convenient, but it's not an addiction to highly processed food caused by an additive supressing any hormone.
So, have we moved from psychology, to addictions, to sociological?
 
mikeyB said:
By highly processed (which is a widely accepted term in nutrition) it's the techniques and additives that make, say, a burger have a longer shelf life, or ready made meals. It's the stuff they put in bread to lengthen shelf life. It's the excess of sugar where it doesn't belong. You see it in the lists of ingredients in, for example, Pot noodles. None of this stuff adds nutrition, it just adds more profit to the manufacturers.

And you know as well as I do, @Docb, that equating all that to natural biological processes is a nonsense.
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Two thoughts...

Most of what is considered to be processing in the food industry is what you and I do in the kitchen all the time. Just about everything I eat is highly processed, just on a smaller scale. The one thing that is different with industrial processing is that additions to enhance flavour or prolong shelf life are often used. Good thing really, we don't want the wholesale poisoning of the populace as favoured by the Victorians. It is a tiny part of processing and is something well controlled by legislation and so maybe not the big deal as you clearly think it is.

Second thought, it is not a good idea to make assertions about what I know or don't know! I know I sometimes revel in an unconventional way of thinking about things. Stood me in good stead when I worked for a living. Don't knock it, it's from that sort of thinking that real progress is made. It rarely comes from strict adherence to dogma.

And I don't make noodles or spaghetti - two reasons. Life is too short and far too many carbs.
 
Docb said:
Most of what is considered to be processing in the food industry is what you and I do in the kitchen all the time. Just about everything I eat is highly processed, just on a smaller scale.
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I don't think there's a convincing sharp line between highly processed food and the (presumably better) rest. But I don't think it's a useless term. I think of it as meaning something like energy dense food, though that would also include honey (which I think wouldn't normally be included).

It feels hard to define without also including things like pasta and breads, and (normally) one wants to approve of traditional cuisines.
 
mikeyB said:
It's all a question of cost, @travellor. Most folk who are living on Universal Credit don't have the time or money to make their own burgers from ground steak, or buy sausages without 30% filler. And yes, Pot noodles as well.

I bet you don't make your own noodles. I do.😉
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Why would people on Universal Credit not have the time compared to everyone else who can find the time?

500g of relatively unprocessed fresh minced beef at Aldi is £1.59. Add a few oxo cubes (pennies) an onion (pennies) and a bit of pasta (under 30p) and that would comfortably feed a family of 4 adults with plenty left over. If you buy the mince frozen you'll get it even cheaper. If you go to Farm Foods/Iceland/Lidl/Aldi you'll get it much cheaper than Asda.

So clearly price isn't the issue either.
If people think price IS still an issue when it comes to food, it's obvious that more education is required.
 
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Docb said:
Second thought, it is not a good idea to make assertions about what I know or don't know! I know I sometimes revel in an unconventional way of thinking about things. Stood me in good stead when I worked for a living. Don't knock it, it's from that sort of thinking that real progress is made. It rarely comes from strict adherence to dogma.
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You could easily be describing me here. 🙂

I have to say Doc, that I'm struggling to think of ANY serious innovation worthy of the name which was created via a strict adherence to dogma.

I was involved in both design and research environments during my career and I didn't come across a single innovator who didn't think differently to other people.
 
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pm133 said:
Why would people on Universal Credit not have the time compared to everyone else who can find the time?

500g of relatively unprocessed fresh minced beef at Aldi is £1.59. Add a few oxo cubes (pennies) an onion (pennies) and a bit of pasta (under 30p) and that would comfortably feed a family of 4 adults with plenty left over. If you buy the mince frozen you'll get it even cheaper. If you go to Farm Foods/Iceland/Lidl/Aldi you'll get it much cheaper than Asda.

So clearly price isn't the issue either.
If people think price IS still an issue when it comes to food, it's obvious that more education is required.
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It would be interesting at least.
20 percent fat mince, with a couple of Oxo cubes and an onion, spooned over pasta?
Or drain the fat off first.
Less than 100g of meat each, saving some for tomorrow.
I don't think I'd like to eat it, so that would save some too.
 
This discussion reminds me of the thread that followed the Dr Chris van Tulleken programme ‘what are we feeding our kids’.

Part of ultraprocessing is to improve texture, flavour etc. Part of it is to extend shelf life, and make things easier / effortless to cook or reheat. Ingredients you wouldn’t find in a domestic kitchen, and ingredient lists that number dozens of ingredients. And the proportion of the average shopping basket that fits that category is increasing.

And that study (the name of which escapes me) showed that people on average ate 500 calories a day more of ultraprocessed foods, than the moderately or minimally processed alternatives. But as @mikeyB says, they still don’t really know why this it. Certainly the presenters n=1 month long 80% ultraprocessed experiment didn’t do him any favours. And his brain showed new ‘addiction-like’ connections. After 4 weeks.

So while there certainly is a degree of personal responsibility, there is also no point in continuing to stigmatise and shame people who are genetically predisposed to be attracted to those foods, and living in a ‘food environment’ where those are cheap, ubiquitous, easy, and borderline addictive.

The shaming-it’s-all-your-own-fault approach has had 20-30 years to have shown how well it works. And here we are.
 
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