The FDA has granted fast track designation to new drugs for the treatment of obesity because they have demonstrated comparable potential to gastric bypass surgery.
– Joey Dweck
TENAFLY, NEW JERSEY, UNITED STATES, Dec. 2, 2022 /EINPresswire.com/ — In October, the US Food and Drug Administration granted Eli Lillys Mounjaro (tirzepatide) Fast Track Designation for its use in the treatment of obesity. The drug was approved in May for the treatment of type 2 diabetes mellitus. Mounjaro is the first weight loss drug to show efficacy rates comparable to surgical procedures such as gastric sleeve surgery. Several other treatments, such as Novo Nordisk’s CagriSema (semaglutide + cagrilintide), are expected to follow after encouraging Phase II data were presented.
The UK and US are both in an obesity crisis. The Health Survey for England 2019 reported that 28% of UK adults were obese and 36.2% were overweight but not obese. In addition, an increase in a sedentary lifestyle, caused in part by the Covid-19 pandemic, led to a further increase in the obese population. The same applies to the USA. A 2017-2018 National Health and Nutrition Examination Survey (NHANES) showed that 30.7% of adults were overweight, 42.4% were obese, and 9.2% were severely obese.
In 1997, the World Health Organization (WHO) classified obesity as a chronic disease. High rates of obesity pose a major burden on healthcare systems as the disease is associated with many serious health complications such as type 2 diabetes, hypertension, non-alcoholic fatty liver disease and other physical dysfunctions. In the United States, treating obesity costs an estimated $147 billion annually in healthcare spending.
In the past, anti-obesity drugs were often discarded due to insufficient efficacy data and the fact that they were associated with a high incidence of side effects. Recently, however, there has been a boom in interest and research into anti-obesity therapeutics. Previously, the standard of care for obesity consisted of holistic dietary changes, exercise, and bariatric surgery for appropriate patients. However, despite the effectiveness of bariatric surgery, many obese patients are reluctant to undergo surgical procedures, opening the possibility for a pharmaceutical approach.
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