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NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EU
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Novo Nordisk A/S (NVO - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending a label update of its blockbuster weekly injection for chronic weight management, Wegovy (semaglutide 2.4 mg).
The CHMP has recommended a label update for Wegovy that reflects reduced heart failure symptoms, improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection fraction (HFpEF), with or without type 2 diabetes.
Following this, Wegovy became the first obesity drug to receive a positive recommendation for a label update to reflect reduced heart failure symptoms and improved physical function by the European regulatory authorities.
Shares of Novo Nordisk have rallied 30.4% so far this year compared with the industry’s increase of 24.1%.
Image Source: Zacks Investment Research
CHMP Opinion Based on NVO’s STEP HFpEF and STEP HFpEF-DM Studies
The latest CHMP opinion for Wegovy label update was based on data from the STEP HFpEF and STEP HFpEF-DM studies, which evaluated the drug in people with obesity-related HFpEF, with or without type 2 diabetes.
Data from both studies showed that treatment with Wegovy when added to the standard of care, led to greater reductions in heart failure-related symptoms and improvements in physical limitations, as measured by the patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (“KCCQ-CSS”), as well as greater weight loss versus placebo.
Also, participants who received Wegovy experienced a larger increase in exercise function, as measured by the difference in 6-minute walking distance (6MWD) from baseline to week 52, compared to participants who received a placebo.
Per management, the positive CHMP recommendation for Wegovy label update in the EU is a key step forward for people with obesity-related HFpEF who have limited treatment options at the moment.
Implementation of the label update in the EU is expected soon.
In the EU, Wegovy’s label was recently expanded to reduce the risks of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack or stroke in adults with established cardiovascular disease and either overweight or obesity without diabetes.
NVO’s Wegovy - a Key Drug in the Obesity Market
Wegovy has become an important revenue driver for Novo Nordisk since its approval. In the first half of 2024, Wegovy recorded sales worth DKK 21.03 billion, representing a surge of 74% year over year, driven by robust demands.
We note that the obesity market is currently dominated by Novo Nordisk and Eli Lilly (LLY - Free Report) , which are the only companies to market obesity drugs.
Lilly’s drug is called Zepbound and contains an ingredient called tirzepatide.
Both Wegovy and LLY’s Zepbound have witnessed unparalleled success in this market space due to exceptionally strong demand. However, both Wegovy and Zepbound are administered as weekly injections.
Novo Nordisk, Lilly and some other drugmakers are also making oral medicines for obesity, which can improve patient convenience.
NVO’s investigational oral obesity pill, amycretin, is currently in early-stage studies.
Lilly is developing orforglipron, an oral GLP-1 small molecule, in late-stage studies.
Viking Therapeutics (VKTX - Free Report) is developing VK2735 as a subcutaneous injection as well as an oral pill for treating obesity.
VKTX plans to advance the subcutaneous formulation of VK2735 to late-stage development and start a mid-stage study on the oral formulation before 2024-end.
Image: Bigstock
NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EU
Novo Nordisk A/S (NVO - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending a label update of its blockbuster weekly injection for chronic weight management, Wegovy (semaglutide 2.4 mg).
The CHMP has recommended a label update for Wegovy that reflects reduced heart failure symptoms, improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection fraction (HFpEF), with or without type 2 diabetes.
Following this, Wegovy became the first obesity drug to receive a positive recommendation for a label update to reflect reduced heart failure symptoms and improved physical function by the European regulatory authorities.
Shares of Novo Nordisk have rallied 30.4% so far this year compared with the industry’s increase of 24.1%.
Image Source: Zacks Investment Research
CHMP Opinion Based on NVO’s STEP HFpEF and STEP HFpEF-DM Studies
The latest CHMP opinion for Wegovy label update was based on data from the STEP HFpEF and STEP HFpEF-DM studies, which evaluated the drug in people with obesity-related HFpEF, with or without type 2 diabetes.
Data from both studies showed that treatment with Wegovy when added to the standard of care, led to greater reductions in heart failure-related symptoms and improvements in physical limitations, as measured by the patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (“KCCQ-CSS”), as well as greater weight loss versus placebo.
Also, participants who received Wegovy experienced a larger increase in exercise function, as measured by the difference in 6-minute walking distance (6MWD) from baseline to week 52, compared to participants who received a placebo.
Per management, the positive CHMP recommendation for Wegovy label update in the EU is a key step forward for people with obesity-related HFpEF who have limited treatment options at the moment.
Implementation of the label update in the EU is expected soon.
In the EU, Wegovy’s label was recently expanded to reduce the risks of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack or stroke in adults with established cardiovascular disease and either overweight or obesity without diabetes.
NVO’s Wegovy - a Key Drug in the Obesity Market
Wegovy has become an important revenue driver for Novo Nordisk since its approval. In the first half of 2024, Wegovy recorded sales worth DKK 21.03 billion, representing a surge of 74% year over year, driven by robust demands.
We note that the obesity market is currently dominated by Novo Nordisk and Eli Lilly (LLY - Free Report) , which are the only companies to market obesity drugs.
Lilly’s drug is called Zepbound and contains an ingredient called tirzepatide.
Both Wegovy and LLY’s Zepbound have witnessed unparalleled success in this market space due to exceptionally strong demand. However, both Wegovy and Zepbound are administered as weekly injections.
Novo Nordisk, Lilly and some other drugmakers are also making oral medicines for obesity, which can improve patient convenience.
NVO’s investigational oral obesity pill, amycretin, is currently in early-stage studies.
Lilly is developing orforglipron, an oral GLP-1 small molecule, in late-stage studies.
Viking Therapeutics (VKTX - Free Report) is developing VK2735 as a subcutaneous injection as well as an oral pill for treating obesity.
VKTX plans to advance the subcutaneous formulation of VK2735 to late-stage development and start a mid-stage study on the oral formulation before 2024-end.
NVO’s Zacks Rank
Novo Nordisk currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.