Novo Nordisk’s blockbuster obesity and weight loss drug Wegovy (semaglutide) has scored a major label expansion after receiving approval from the US Food and Drug Administration (FDA) for a heart indication to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.
The expanded approval makes Wegovy the first weight loss drug to also be approved for the prevention of cardiovascular events in adults with heart disease and either obesity or overweight.
Wegovy is used in conjunction with dietary modifications and physical activity to help individuals lose weight.
According to the FDA, obesity or overweight affects approximately 70 percent of American adults. Both are serious health issues that increase the risk of premature death and various health problems such as heart attack and stroke.
Experts say that the battle between GLP-1 obesity/weight loss front-runners Wegovy and Eli Lilly’s Zepbound (tirzepatide) will now largely be determined by which drug has the “best label.”
In a social media post, former FDA Commissioner Scott Gotlieb, MD, said, “For a time, Wegovy is going to have the better label, even if Zepbound may be a better drug.”
Since the approval of its semaglutide products Wegovy and Ozempic in 2021, Novo Nordisk has soared to unimaginable heights. According to Danske Bank, the Danish drugmaker has been so profitable that it has given the Danish economy a boost that will continue into 2024.
Related: New Wegovy TV Commercial Launched After Pause to Deal with High Demand
Wegovy’s broader label might make it more attractive for insurers to cover over Zepbound, which could lead to “even more aggressive discounting from Lilly,” Gottlieb added.
Currently, many insurers do not cover Wegovy. Patient advocacy group Obesity Action Coalition said they hope the additional approval may change that.
The group said insurers “should have been providing coverage for anti-obesity medications prior to the announcement. Now, there should be no doubt that this treatment must be covered. Lives are at stake.”
Wegovy’s efficacy and safety for its heart indication were assessed in Novo’s Phase III SELECT cardiovascular outcomes trial that included 17,604 participants who received either Wegovy or placebo, along with standard-of-care treatment like management of blood pressure and cholesterol and counseling about diet and physical activity.
Among those who received Wegovy, the risk of major adverse cardiovascular events (MACE), including cardiovascular death, heart attack and stroke, was cut by 20 percent compared to those who received placebo.
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In a press release announcing the approval, Novo revealed that the heart benefits lasted up to five years regardless of baseline body mass index (BMI) or level of renal function impairment. The company said Wegovy’s updated label includes data from SELECT showing a 15 percent risk reduction in cardiovascular death and a 19 percent reduction in the risk of death from any cause compared to placebo.
“We are very pleased that Wegovy is now approved in the US as the first therapy to help people manage their weight and reduce cardiovascular risks,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. “This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events.”
Novo Nordisk said it has also filed for a label expansion in the European Union (EU) with a decision expected in 2024.
The prescribing information for Wegovy contains a boxed warning about the risk of thyroid C-cell tumors. Given the risk, the FDA said Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called multiple endocrine neoplasia syndrome type 2.
Wegovy was first approved in June 2021 for chronic weight management in adults with obesity (BMI ≥ 30) or with overweight (BMI ≥ 27) with at least one weight-related condition. The indication was later expanded to include children 12 years of age and older with obesity.
Skyrocketing demand for Novo’s semaglutide products led to significant shortages of Wegovy, Ozempic and Rybelsus (oral semaglutide for type 2 diabetes treatment). In an investor’s call earlier this year, Novo’s chief financial officer Karsten Munk Knudsen said the company has more than doubled its supply of starter doses.
In January, Novo also resumed advertising for Wegovy after hitting the brakes on promotions in May 2023 due to the shortages. The drug remains on the FDA’s drug shortages list. Eli Lilly’s GLP-1 products Mounjaro (tirzepatide) and Zepbound have been facing similar shortages.
In 2023, global sales of Wegovy reached a staggering $4.6 billion.
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