Britain's Drug Regulator Approves Novo Nordisk's Weight Loss Drug Wegovy To Cut Heart Disease Risk In Obese Patients

On Tuesday, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for Novo Nordisk A/S’s NVO semaglutide (Wegovy) to reduce the risk of overweight and obese adults suffering heart problems or strokes.

This medicine, a GLP-1 receptor agonist, was already approved for use in the treatment of obesity and weight management, alongside diet, physical activity, and behavioral support.

Also Read Oral Weight Loss Drugs Vs. Injections – Pills Are Promising Yet Challenging Frontier.

The approval means that semaglutide is the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart attack, and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2.

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) lowers the incidence of major adverse cardiovascular events (MACE) vs placebo.

In a multi-national trial that randomly assigned over 17,600 participants to receive either Wegovy or a placebo, Wegovy significantly reduced the risk of major adverse cardiovascular events by 20%, such as cardiovascular death, heart attack and stroke, which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received placebo.

Several recent studies have shown us that semaglutide is an effective tool that can improve the quality of life for those with cardiovascular disease, including by lowering the risk of serious cardiac events.

Novo Nordisk also bought a 200-acre site in Denmark’s third-largest city, Odense, earlier this month and will begin preparatory excavation works for a potential new production plant.

Due to high demand, the company has invested billions to increase production in Denmark and the U.S. While the purpose of their new Odense site remains unclear, Reuters, citing a January environmental report, suggests it will house facilities for filling injection pens, a process known as fill-finish.

“With the political processes and approvals in place, we are pleased to announce that Novo Nordisk is now the owner of the site in Tietgenbyen in Odense,” Reuters noted, quoting the company’s emailed statement.

“We are still awaiting the outcome of our internal approval process before we can take the final decision at the end of the year,” it said.

According to the environmental report, the plans include building a packaging facility by 2026 and molding plastic components for pen and potentially tablet production by 2030.

Price Action: NVO stock is up 0.24% at $133.50 at the last check on Tuesday.

Read Next:

• Novo Nordisk’s Wegovy Demonstrates Greater Weight Loss In Women With Heart Condition.

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