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 1st time the agency has endorsed such a treatment in several years.
Wegovy, a weight-management therapy to be manufactured by Danish drug company Novo Nordisk, is that the the 1st FDA-approved weight-loss drug since 2014, but it isn’t entirely a latest new medication.
The same drug, called semaglutide, has been utilized in the US and other countries as an anti-diabetic medication for years. More recently, however, evidence has shown that semaglutide at a special dosage also functions as a strong and effective appetite-suppressant.
In a study published earlier within the year involving almost 2,000 obese adults from 16 different countries, researchers reported that long-term treatment with the drugs led to almost 15 percent weight loss on the average across the cohort.
Some lost even more, with over 30 percent of the group dropping in more than 20 percent of their weight – results that the scientists singled out as remarkable.
“No other drug has compared to producing this level of weight loss – this really may be a game-changer,” obesity researcher Rachel Batterham from University College London said at the time.
“For the 1st time, people are able to do 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 a minimum of one weight-related condition (such as High BP , type 2 diabetes, or high cholesterol).
The therapy, which is predicted to be launched by Novo Nordisk in US later this month, comes within the form of a once-weekly injection, delivering the hormone glucagon-like peptide-1 (GLP-1) that creates recipients feel fuller, helping them to subsequently eat less.
In approving the Wegovy formulation, the FDA considered the results of 4 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 counting on certain trial parameters, but Novo Nordisk says a mean weight loss of 17-18 percent was sustained for over 68 weeks in people with obesity (and without type 2 diabetes) who took Wegovy additionally to adopting a reduced calorie meal plan and increased physical activity.
By contrast, the placebo group experienced much lower weight loss. In one among the trials – during which the Wegovy group experienced 14.9 percent of weight loss on the average – the placebo group showed just 2.4 percent weight loss in otherwise identical conditions, suggesting semaglutide goes how to helping people eat less.
Given that almost three-quarters (73.6 percent) of adults within the US aged 20 or over are either overweight or obese, it’s hoped that the new drug could help many thousands of USA citizens with weight-related ailments to manage 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 within the studies, including nausea, diarrhea, vomiting, constipation, and abdominal pain.
These discomforts were enough for a few within the group to discontinue treatment, except for many that didn’t feel the side effects – or grimaced through them – potentially life-transforming weight loss was achievable.
“This is that the first time we’ve seen this magnitude of weight loss with a drugs ,” 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 haven’t been demonstrated with an anti-obesity medicine before.”
While the promise of Wegovy holds the potential to assist an enormous amount of USA citizens gain control over their weight, an unfortunate barrier to several are going to be cost of entry.
While Novo Nordisk hasn’t yet confirmed the medication’s price, there are indications the corporate may charge in the vicinity of US$1,300 a month without insurance for this game-changer.
Which sadly means, for several Americans a minimum of , this potentially life-transforming medication won’t be accessible any time soon – and they’ll need to keep trying to change-the-game on their own for now.
The research on Weight Loss Drug previously published on 11 Feb,2021.