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Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved the NDA (New Drug Application) for the treatment of obesity – Wegovy™ (higher dose of semaglutide) injection 2.4 mg. Semaglutide drug is used to treat type-2 diabetes and, its more potent avatar is the first-and-only prescription weight-loss medication with once-weekly dosing. Also Read: Ocugen pays $15 mn to Bharat Biotech for Covaxin rights in Canada
What do we know: Nearly 42% of all adults in the US live with obesity. CDC has called it an epidemic as obesity is associated with almost 60 other serious health conditions. It eventually decrease life expectancy. Also Read: Diet and arthritis: Low calorie diet can help arthritis patients better manage symptoms
The approval of the weight-loss prescription from Novo Nordisk was based on a clinical trial program called STEP (Semaglutide Treatment Effect in People with Obesity) which included four-phase 3a clinical trials involving nearly 4500 patients. The Wegovy is used with a calorie deficit meal plan and increased physical activity for adults with obesity (having BMI greater than 30). The drug can also be used by people who have weight issues and it can help them lose weight and stay healthy. Also Read: Explained: Here’s why some people who get COVID-19 don’t fall sick. It’s all in the genes!
How does it work: The drug helps the patient by suppressing his/her appetite as it balances the hormones like insulin. Eventually, people shed their extra weight as they eat less. Also Read: Poor nutrition during school years can stunt children’s growth: study
STEP clinical program: As per the study, the test achieved an average weight loss of 14.9% patients who were given Wegovy drug at 68 weeks versus 2.4% for placebo. Additionally, 83.5% of patients achieved over 5% weight reduction with the Wegovy drug as compared to 31.1% for placebo.
Some of the side effects of the drug are events like nausea, diarrhoea, vomiting, constipation, and abdominal pain.
What’re they saying: “This is the first time we have seen this magnitude of weight loss with a medicine. This approval gives people with obesity a once-weekly, non-surgical option with results that have never been demonstrated with an anti-obesity medicine before,” said Dr Robert Kushner, professor of medicine and medical education at Northwestern University, Feinberg School of Medicine, Chicago. “The approval of Wegovy represents a turning point for healthcare providers to embrace medical management of obesity to help improve chronic weight management for patients.”
“Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “We are excited about the regulatory filing of semaglutide 2.4 mg in the US and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity.”