In Wednesday’s pre-market trading, shares of Novo Nordisk A/S NVO are witnessing a fall after the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for Novo Nordisk’s semaglutide, Wegovy, to reduce the risk of heart complications or strokes in overweight and obese adults,
What Happened: At the time of writing, Novo Nordisk was trading 1.25% lower at $131.61 in the pre-market after closing at $133.28 on Tuesday, according to Benzinga Pro.
The weak pre-market performance can also be linked to increased competition in the weight loss drugs market. Last week, shares of Novo Nordisk and rival Eli Lilly LLY dipped after Pfizer Inc. PFE and Roche RHHBY announced their advancements in obesity-fighting drugs.
Wegovy, a GLP-1 receptor agonist, had previously been approved for use in obesity treatment and weight management, in combination with diet, physical activity, and behavioral support.
This latest approval marks semaglutide as the first weight loss drug to be prescribed for the prevention of cardiovascular events, such as cardiovascular death, non-fatal heart attack, and non-fatal stroke, in individuals with established cardiovascular disease and a Body Mass Index (BMI) of 27 kg/m2 or higher.
The approval is based on new data from a post-approval clinical study, which demonstrated that semaglutide (2.4 mg once weekly by subcutaneous injection for up to five years) reduces the occurrence of major adverse cardiovascular events (MACE) compared to a placebo.
Why It Matters: This approval comes after Novo Nordisk acquired Cardior Pharmaceuticals GmbH in April, a biotech company focusing on heart diseases, as the Danish pharma giant sought to build its heart drugs pipeline.
In June, Wegovy demonstrated greater weight loss in women with prevalent heart disease than in men with the same condition. The drug led to similar improvements in heart failure symptoms in both genders, but women lost an average of 9.6% of their weight, compared to men who lost about 7.2% of body weight.
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Photo by Tobias Arhelger via Shutterstock
This story was generated using Benzinga Neuro and edited by Pooja Rajkumari
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