- The FDA has accredited the medicine Wegovy, the next dose of the diabetes drug semaglutide, for use as a weight administration drug in sufferers with weight problems.
- In scientific trials, contributors with out diabetes who took Wegovy misplaced a mean of 12.4 % of their preliminary physique weight.
- The drug is an artificial model of a intestine hormone that suppresses starvation and urge for food.
A diabetes drug has acquired approval from the Food and Drug Administration (FDA) to even be used as a weight-loss medicine in sufferers with weight problems.
The medicine, Wegovy, is the next dose of the diabetes drug semaglutide produced by Novo Nordisk.
It’s the primary drug for persistent weight administration that has been accredited by the FDA since 2014.
Wegovy, administered through a once-weekly injection, is indicated for individuals with a physique mass index (BMI) of 27 kg/m2 or greater and who’ve at the least one weight-related medical situation resembling hypertension or excessive ldl cholesterol. The medicine can be for individuals who have a BMI of 30 kg/m2 or greater.
In the United States, roughly 1 in 3 adults — over 100 million individuals — have weight problems. Treating weight problems can enhance blood stress, blood sugar, and levels of cholesterol.
“Today’s approval affords adults with weight problems or obese a helpful new therapy choice to include right into a weight administration program,” Dr. John Sharretts, the deputy director of the Division of Diabetes, Lipid Disorders, and Obesity within the FDA’s Center for Drug Evaluation and Research, mentioned in
Wegovy is an artificial model of a hormone within the intestine, glucagon-like peptide-1, that impacts the elements of the mind that management starvation and urge for food.
It is injected underneath the pores and skin as soon as per week.
“It slows emptying of the abdomen. It promotes the sensation of fullness (satiety) by appearing on the mind, significantly on the degree of the hypothalamus,” mentioned Dr. Aleem Kanji, a board-certified endocrinologist and weight problems medication doctor with Ethos Endocrinology in Houston.
In scientific trials evaluating the protection and efficacy of Wegovy for weight reduction, contributors with out diabetes who took Wegovy misplaced, on common, 12.4 % of their preliminary physique weight in comparison with those that acquired a placebo.
In a scientific trial performed in individuals with kind 2 diabetes, those that took Wegovy misplaced 6.2 % of their physique weight in comparison with those that acquired a placebo.
Those who took Wegovy misplaced weight steadily for 16 months earlier than plateauing.
Gastrointestinal points — diarrhea, vomiting, constipation, stomach ache, indigestion, flatulence — have been generally reported unintended effects. These unintended effects sometimes resolved on their very own, however 5 % of contributors stopped taking the medicine due to them.
Other contributors reported headache, fatigue, and dizziness.
“Individuals with weight problems and sort 2 diabetes are seemingly good candidates for the twin advantage of improved blood sugar management and weight reduction,” mentioned Kanji.
According to Kanji, knowledge suggests Wegovy has a good security profile in comparison with older weight loss medications.
Wegovy shouldn’t be used with different medication used for weight reduction or drugs that include semaglutide, in line with the FDA.
Wegovy has a possible danger of thyroid C-cell tumors and must also not be given to individuals with a private or household historical past of medullary thyroid carcinoma and Multiple Endocrine Neoplasia syndrome kind 2 (MEN 2).
The drug has not been studied in individuals who have a historical past of pancreatitis.
The drug, at a dose of 1 mg, was first accredited for kind 2 diabetes in 2017.
Kanji plans so as to add Wegovy as a therapy choice for sure sufferers with weight problems — particularly these with kind 2 diabetes.
The price is anticipated to be just like Saxenda, which prices $1,349 a month with out insurance coverage.
“As is commonly the case, price and medical health insurance protection would be the limiting issue,” mentioned Kanji.
The Food and Drug Administration has accredited the diabetes drug semaglutide for use as a weight-loss medicine in sufferers with weight problems. The drug is an artificial model of a intestine hormone that suppresses starvation and urge for food. In scientific trials, contributors who took the medicine misplaced about 12 % of their physique weight in comparison with those that took a placebo. This is the primary drug the FDA has accredited for weight reduction since 2014.