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’s just a common diabetes drug with a new name and at a higher dose.
Hint, hint.
And a big, big price
The usual routine:
1 wonder drug announced.
2 drug sells like hotcakes.
3 side effects thst were suppressed in the trials documentation rear their ugly heads.
4 drug withdrawn.
5 No one is punished either at the FDA or the drug company for the fraud and damaged users.
“common diabetes drug ... higher dose”
which means one of two things:
A. one can expect it to cause hypoglycemia for those who already have normal or low blood sugar ...
B. It never worked as a diabetes drug ....
“My advice to you is to, uh, avoid any type of food product that your neighborhood supermarket might try to sell you.” - The Ladies Man (Tim Meadows), Saturday Night Live.
$15k per year, and may cause thyroid cancer and kidney failure.
Simpler and cheaper to just back off on the carbs.
yeah, i think i’d let Mikey try it first ...
Ping
Here’s a thought.
1. Eat less calories. Especially but not exclusively carbohydrates such as breads and pasta, alcohol, soda. Eat smaller portions. Stop eating at fast food places.
2. Burn more calories. Get exercise. Don’t drive so much.
It’s that simple.
And a new trademark protecting it.
Remember when PhenFen came out in the 1990s and was a game changer for weight loss? And it was effective at weight loss. About a year later they discovered it was also effective damaging cardiac valves.
at 333 dollars per injection apparently
Exactly what happens. Then the law firms hit the airwaves looking for victims.
Novo is notorious for holding their drugs in high esteem.
Be very careful of what your doctor prescribes as there are almost always alternatives that are more fairly priced. I see this as particularly true for maladies that are in vogue or common such as Type 2, HBP, chronic pain and arthritis.
If I cut the carbs and switch to fats I can eat until I feel sick at meals and lose weight.
Keeping to a reasonably low carb diet lets me maintain a good weight.
Don’t change what you stuff in the pie hole, take a shot and don’t worry about potential complications resulting from a type 2 diabetics drug that increases insulin production. Don’t quite understand that either as diebetics have problems processing insulin at cellular level. Why should anyone want them making more? Good medicine doesn’t mean good health unless it means production of a revenue stream.
WARNING: RISK OF THYROID C-CELL TUMORS
In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
Ozempic® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Ozempic® and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®.
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