On the 4th of June 2021, the U.S Food and Drug Administration approved a new weight management drug known as Wegovy (semaglutide). This drug is for obese or overweight adults with at least one weight-related condition (such as type 2 diabetes, high blood pressure, or high cholesterol).
What you need to know
- The said adults must take this drug in addition to a balanced diet and physical activity.
- The patient must be injected with 2.4 mg once a week.
- The patient must have a body mass index (BMI) of 27 kg/m2 or greater.
John Sharretts, M.D., deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Centre for Drug Evaluation and Research, said that FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” he said
According to the FDA, semaglutide’s safety and efficacy were studied in four 68-week trials, three of which were randomized trials. More 2 600 patients received semaglutide in 68 weeks. At the beginning of the trial, the average age of patients was 46 years, and 74 % of them were females with an average weight of 105 kg and an average BMI was 38 kg/m2. Patients who received the drug lost an average of 12,4 % compared to their initial body weight.
What are the side effects of semaglutide?
- Nausea
- Diarrhoea
- Vomiting
- Constipation
- Abdominal (stomach) pain
- Headache
- Fatigue
- Dyspepsia (indigestion),
- Dizziness
- Abdominal distension
- Eructation (belching)
- Hypoglycemia (low blood sugar) in patients with type 2 diabetes
- Flatulence (gas buildup)
- Gastroenteritis (an intestinal infection)
- Gastroesophageal reflux disease (a type of digestive disorder).
Medical Brief reported that trials for this new drug were done in 12 countries across Europe, North America, South America, the Middle East, South Africa, and Asia.