United States – The UK regulator gives Novo Nordisk’s (NOVOb. CO) Wegovy green light for risk reduction of severe heart issues or stroke in overweight and obese adults, the agency said on Tuesday.
The approval from the UK’s Medicines and Healthcare products Regulatory Agency comes closely on the heels of a similar clearance from the U.S. Food and Drug Administration in March.
Health Impact
In deciding on MHRA’s approval, Wegovy is the first GLP-1 weight loss medication to be used in the prevention of cardiovascular events among the obese population, according to the agency.
“This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity,” Shirley Hopper, MHRA’s deputy director of innovative medicines, said.
Currently, around 7.6 million people in the United Kingdom suffer from cardiovascular diseases, the British Heart Foundation has indicated, while one in every six deaths from heart and circulatory related disease in England can be sourced to high body mass index.
Wegovy approval came from a trial that demonstrated that it decreases the incidence of major cardiovascular problems such as heart attack and stroke by 20% compared to the placebo.
Clinical Trial and Results
It included more than 17,600 overweight persons and those with obesity receiving the drug dose once weekly or placebo over an average of 33 months, as reported by Reuters.