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FDA Approves “Game Changer” Semaglutide for Weight Loss

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The US Food and Drug Administration (FDA) has approved a weekly 2.4 mg subcutaneous dose of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy, Novo Nordisk) for weight loss.

Specifically, the form and dosage of this drug has been approved as an aid to a low-calorie diet and increased physical activity to treat obese adults (BMI). [BMI] ≧ 30kg / m2) Or overweight (BMI ≥ 27 kg / m)2) There is at least one weight-related comorbidity.

According to the company, semaglutide “causes weight loss by reducing hunger and increasing satiety, thereby reducing people’s diet and calorie intake.” statement..

Game changer STEP Drugs tested in clinical trial programs

The FDA’s favorable ruling is based on the results of the Semaglutide Therapeutic Effect (STEP) program in four Phase 3 clinical trials that tested the safety and efficacy of the drug in more than 4,500 obese or obese adults.

Four 68-week trials of semaglutide 2.4 mg / week subcutaneously and placebo New England Journal of Medicine (step 1), Lancet (Step 2),and JAMA (Step 3, Step 4) February and March 2021.

As previously reported Medscape Medical News, All trials were in overweight or obese adults.

  • step 1 I was an adult in 1961.

  • Step 2 There were 1210 adults with diabetes.

  • Step 3 It included 611 adults, and people in the treatment group also received intensive lifestyle interventions.

  • Step 4 Was performed on 803 adults who reached a target dose of 2.4 mg semaglutide after 20 weeks of break-in (the study investigated further weight loss over the next 48 weeks).

In trials 1, 2, and 4, overweight and obese patients were treated with the semaglutide group. Achieved Weight loss of 15% to 18% in 68 weeks.

The dose was well tolerated. The most common side effects were the gastrointestinal tract, which were transient, mild or moderately severe.

At the time of this announcement, co-author of the STEP 1 study, Rachel Batterham (MBBS, PhD) of the Obesity Research Center at University College London, UK, said: Obese person. “

“No other drug can achieve this level of weight loss. It’s just a game changer. For the first time, people can achieve what was possible only with drugs. Weight loss surgery, “She added.

Low dose injections and tablets for diabetes have already been approved

Up to 1 mg / week of subcutaneous semaglutide (Ozempic, Novo Nordisk), offered as a 0.5 mg or 1.0 mg prefilled pen, has already been approved for the treatment of type 2 diabetes.

The company is also applying for approval of a high dose (2 mg / week) of semaglutide for use in type 2 diabetes. resubmit A label extension request to the FDA after the FDA refused to submit the letter in March.

And in September 2019, FDA approval Oral semaglutide (Rybelsus, Novo Nordisk), doses 7 and 14 mg / day, improve glycemic control in type 2 diabetes and become the first GLP-1 receptor agonist available in the form of tablets.

CVOT and oral form tests for obesity

Effect of ongoing semaglutide on heart disease and stroke in overweight or obese patients (select) Trial To shed light on Cardiovascular outcomes after 2.5-5 years in patients with cardiovascular disease and overweight or obesity but not type 2 diabetes. Participants receive up to 2.4 mg / week of semaglutide or placebo as an adjunct to lifestyle recommendations focused on reducing cardiovascular risk. The study is expected to be completed in 2023.

And Novo Nordisk Scheduled to start A 68-week, phase 3 international study in the second half of 2021 comparing the efficacy and safety of oral semaglutide 50 mg with placebo in 1000 people with obesity or overweight and comorbidities.

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