Posted on 06/09/2021 9:00:36 AM PDT by Red Badger
A weight-loss drug described as a 'game-changer' by obesity researchers has just been approved by the US Food and Drug Administration (FDA), representing the first time the agency has endorsed such a treatment in several years.
Wegovy, a weight-management therapy to be manufactured by Danish pharmaceutical company Novo Nordisk, is the the first FDA-approved weight-loss drug since 2014, but it's not entirely a new medication.
The same drug, called semaglutide, has been used in the US and other countries as an anti-diabetic medication for years. More recently, however, evidence has shown that semaglutide at a different dosage also functions as a powerful and effective appetite-suppressant.
In a study published earlier in the year involving almost 2,000 obese adults from 16 different countries, researchers reported that long-term treatment with the medicine led to almost 15 percent weight loss on average across the cohort.
Some lost even more, with over 30 percent of the group dropping in excess of 20 percent of their body weight – results that the scientists singled out as remarkable.
"No other drug has come close to producing this level of weight loss – this really is a game-changer," obesity researcher Rachel Batterham from University College London said at the time.
"For the first time, people can achieve through drugs what was only possible through weight-loss surgery."
Now, the FDA has taken notice. On Friday, the agency announced that Wegovy (semaglutide) had been approved for chronic weight management in adults who are either obese or overweight, and who have at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol).
The therapy, which is expected to be launched by Novo Nordisk in the US later this month, comes in the form of a once-weekly injection, delivering the hormone glucagon-like peptide-1 (GLP-1) that makes recipients feel fuller, helping them to subsequently eat less.
In approving the Wegovy formulation, the FDA considered the results of four separate double-blind, placebo-controlled clinical trials, running for 68 weeks, and involving approximately 4,500 patients in total, who randomly received either Wegovy or a placebo.
Results differed marginally across each trial depending on certain trial parameters, but Novo Nordisk says an average weight loss of 17 to 18 percent was sustained for over 68 weeks in people with obesity (and without type 2 diabetes) who took Wegovy in addition to adopting a reduced calorie meal plan and increased physical activity.
By contrast, the placebo group experienced much lower weight loss. In one of the trials – in which the Wegovy group experienced 14.9 percent of body weight loss on average – the placebo group showed just 2.4 percent weight loss in otherwise identical conditions, suggesting semaglutide goes some way to helping people eat less.
Given that almost three-quarters (73.6 percent) of adults in the US aged 20 or over are either overweight or obese, it's hoped that the new drug could help many thousands of Americans with weight-related ailments to regulate their food intake.
For those whose health renders them eligible for the treatment, it's worth noting that mild-to-moderate effects were reported by many participants in the studies, including nausea, diarrhea, vomiting, constipation, and abdominal pain.
These discomforts were enough for some in the group to discontinue treatment, but for many who didn't feel the side effects – or grimaced through them – potentially life-transforming weight loss was achievable.
"This is the first time we have seen this magnitude of weight loss with a medicine," says obesity expert Robert Kushner from Northwestern University, who oversaw the research.
"This approval gives people with obesity a once-weekly, non-surgical option with results that have never been demonstrated with an anti-obesity medicine before."
While the promise of Wegovy holds the potential to help a huge amount of Americans gain control over their weight, an unfortunate barrier to many will be cost of entry.
While Novo Nordisk hasn't yet confirmed the medication's price, there are indications the company may charge in the vicinity of US$1,300 a month without insurance for this game-changer.
Which sadly means, for many Americans at least, this potentially life-transforming medication won't be accessible any time soon – and they'll have to keep trying to change the game on their own for now.
It is very hard for some of us to avoid overeating and “remain dedicated to the task.” I also have lost a lot of weight, then over several years regained all that was lost and more. The best weight loss I had was after moving to Switzerland and being shocked at the price of food. I couldn’t bring myself to paying their exorbitant prices - and that motivation enabled me to lose about 50 lbs. Unfortunately for my weight I had to move back to the U.S. and cheap food again got the better of me. Knowing there is a huge cost to health and for medications tied ultimately to weight should be enough motivation, but not as direct as paying essentially $12 for what at the time was a $1 worth of food.
Every rose has its thorns......................
6 Lawyers solicit “victims” to come forward for “deserved” compensation.
7 In the end the FDA regulators get cozy jobs at the drug companies
8 repeat starting at 1
Ozempic is the same drug as Wegovy. I don’t know about elequis.
Actually it does work, I’ve been on Trulicity for over a year >20% reduction in A1C and 15% weight loss. The side effects are real - nausea mostly - but are worth it as my A1C is now in the non-diabetic range.
Benfotiamine & Berberine have no such side effects. Over the counter. I am very impressed with the Berberine. More effective than Metformin, too.
Eliminate soda, fruit juices/drinks, rice, bread, pasta, sugar and processed carbs (80% of the battle right there).
Eat within a 2 to 4 hour window each day (I personally do one meal a day, but others may choose a different strategy)
Exercise by walking, taking the stairs instead of the elevator, simple dumbbell exercises, pushups and other calisthenic or body-weight exercises if you can't use weights or exercise bands.
Do a complete fast of water only, once a week. I typically fast from early Sunday afternoon until about noon on Tuesday (approximately 45 hours). Alternatively; I do a 72 hour fast (water-only) once a month. Drink copious amounts of water while fasting. Incidentally; the fasting is for autophagy and healing and has nothing to do with weight loss.
Anecdotally; I haven't had so much as a sniffle since 2014 when I started down this path.
Always looking for the external, "quick fix" solution like the pill or the shot is a recipe for disaster as there are always side effects that may be worse than what you are trying to 'cure'. I'll pass on this "wonder drug".
I’m guessing the latest patent extension is about to expire.
I tried the pill form of semaglutide, but my insurance company would only cover the injectable.
I’ve already had plenty of needles in the last few years, so I passed. The cost without insurance was $3,000/month.
I tolerated it pretty well, but it wasn’t without some gastrointestinal distress, especially initially. But for me, the distress was additive, as I take other drugs that cause a lot more distress.
I struggle with my weight. I diet aggressively, and work out five days a week. But I lead a fairly inactive life-style. It’s hard to overcome for me. I’m disabled now, and and have trouble getting about.
I noticed I was gaining weight early in the lockdowns, and decided to crank it up on the diet and exercise, and went from net 8 lbs. up to net 15 down.
My doctor said that at my current BMI, I’d probably only lose another 5% of body weight, but for me, that’d be pretty fantastic!
For those who are serious about weight, especially for health reasons, who already have other health issues with which to contend, this drug could be a very good supplement to the program.
I just don’t want to do another needle. Wish my insurance company would cover the pill.
Maybe they will now that it’s FDA approved for this condition!..............
Same. I eat whatever I want, even dessert....but it’s my only meal of the day. I have found I don’t eat much anymore either.
Wegovy is still an injectable.
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