FDA Approves 'Game Changer' Drug for Weight Loss In clinical trials, participants lost up to 15

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WebMD 07 June, 2021 - 04:06pm 92 views

When can I get Wegovy?

Wegovy is indicated for adults who are obese (body mass index ≥30) or overweight (body mass index ≥27), and who also have certain weight-related medical conditions, such as type 2 diabetes, hypertension, and high cholesterol. ForbesNewly Approved Obesity Drug Wegovy Holds Promise, But Faces Reimbursement Challenges

What is the name of the new weight loss drug approved by the FDA?

June 7, 2021 — The FDA has approved a drug to help in weight loss among overweight or obese adults. The drug, semaglutide, "induces weight loss by reducing hunger, increasing feelings of fullness, and thereby helping people eat less and reduce their calorie intake," according to a company statement. WebMDFDA Approves 'Game Changer' Drug for Weight Loss In clinical trials, participants lost up to 15

How much does Wegovy cost?

Dive Brief: The Food and Drug Administration on Friday approved Novo Nordisk's newest treatment for obesity, a weekly injection called Wegovy. The Danish company followed up Monday with an announcement that it will set the list price at $1,297 a month, equivalent to its daily obesity drug Saxenda. BioPharma DiveNovo keeps price in line with FDA approval of second obesity shot

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The Food and Drug Administration (FDA) on Friday approved a weight loss drug for overweight or obese adults, marking the first such authorization since 2014. The drug, Wegovy, is an under-the-skin injection meant to be used in addition to a reduced-calorie diet and increased physical activity. 

"Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program," John Sharretts, M.D., deputy director of the Division of Diabetes, Lipid Disorders and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a news release. "FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight." 

The drug works by mimicking the glucagon-like peptide-1 hormone which targets areas of the brain that helps regulate appetite and food intake. The FDA warned that it should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other weight loss products including herbal products, over-the-counter drugs or prescription drugs. 

The dosage is meant to be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects. 

The approval comes after four 68-week successful trials which involved over 2,600 patients. The participants saw a 6.2% decrease in their initial body weight compared to an additional 1,500 patients who received a placebo. 

The most common side effects reported included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, gas, gastroenteritis, hypoglycemia in patients with type 2 diabetes, and others. 

The FDA said approximately 70% of American adults are obese, which has been linked to leading causes of deaths such as heart disease, stroke and diabetes as well as an increased risk for certain cancers.  Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease among this population. 

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Read full article at WebMD

FDA approves drug for weight loss

FOX59 News 08 June, 2021 - 12:01pm

Wegovy: For first time since 2014, FDA approves new drug semaglutide for chronic weight management

WTVD-TV 08 June, 2021 - 12:01pm

FDA approves new drug for chronic weight management

Risk of patient overlap between Wegovy and Saxenda obesity drugs, Novo says

Reuters 08 June, 2021 - 12:01pm

A 2.4 milligram dosage of Novo Nordisk's semaglutide drug was approved by the U.S. Food and Drug Administration (FDA) on Friday under the name Wegovy, and will be launched on June 10. read more

Shares in Novo Nordisk traded up 0.56% at 0828 GMT.

Semaglutide belongs to a range of new diabetes and obesity drugs known as GLP-1 analogues, which by imitating a gut hormone that stimulates insulin production, lower appetite and increase feelings of fullness in patients.

Novo already has one GLP-1 obesity drug on the market, Saxenda, launched in 2015, but with the introduction of Wegovy to the U.S. market, an overlap between patients could occur, it said.

"There is of course a risk of some cannibalisation between Wegovy and Saxenda and lower initial value per script, while we build the access for Wegovy," Novo's executive vice president of commercial strategy, Camilla Sylvest, told an investor briefing.

"Our focus is to start new patients on Wegovy rather than switching patients currently benefiting from Saxenda," Sylvest added.

Unpublished data from a new trial study called STEP 5 showed treatment with Wegovy over almost two years led to an average weight loss of 17%, with 40% of patients losing 20% or more of body weight, Novo said on Monday.

Sydbank analyst Soren Lontoft Hansen estimated that Wegovy as a "best in class" drug would be able to open a "potentially very attractive", yet undeveloped obesity drug market.

"Going forward, we expect the obesity market - with the prospect of more innovation being introduced - will grow much faster than Novo Nordisk's other businesses," Hansen, who has a "buy" rating on Novo, said.

Novo also said Wegovy, a once-weekly injectable, would be launched at similar list prices in the United States as Saxenda.

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FDA approves weight loss drug for the first time in seven years | TheHill

The Hill 08 June, 2021 - 12:01pm

 Wegovy is taken as an injection.

Officials gave the green light to the prescription drug semaglutide, under the brand name Wegovy, for adults struggling with obesity or being overweight who also have a second related condition, such as high blood pressure, type 2 diabetes, or high cholesterol. 

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