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Lilly's Zepbound Receives FDA Approval for Sleep Apnea
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Eli Lilly and Company (LLY - Free Report) announced that the FDA has approved its popular obesity drug, Zepbound (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. OSA is a common sleep-related breathing disorder that causes repeated interruptions in breathing (apnea) or shallow breathing (hypopnea) during sleep. OSA marks the second indication for Zepbound. The drug was approved to treat obesity or overweight issues in November 2023.
With the approval, Zepbound becomes the first and only prescription drug approved for treating for adults with moderate-to-severe OSA and obesity.
LLY’s stock was up 1.4% on Friday. It is also up in-premarket trading on Monday in response to the new approval. Also, rival Novo Nordisk (NVO - Free Report) announced disappointing data from a late-stage study on its next-generation obesity drug, CagriSema, on Friday, which also pushed LLY’s stock up.
Lilly’s stock has risen 31.7% so far this year compared with an increase of 1.4% for the industry.
Image Source: Zacks Investment Research
More on the FDA Approval for LLY’s Zepbound for OSA
Zepbound’s approval for OSA was based on data from SURMOUNT-OSA phase III studies, which showed that patients not on positive airway pressure (PAP) therapy taking Zepbound experienced 25 fewer breathing disruptions per hour compared to five with placebo. In adults taking PAP therapy, Zepbound led to 29 fewer breathing disruptions per hour compared to six with placebo. In addition to improved OSA symptoms, in adults with PAP therapy, Zepbound also led to an average weight loss of 20%. The studies also showed that around 50% of the patients experienced such improvements with Zepbound that they no longer had symptoms associated with OSA after one year.
Lilly’s regulatory application seeking approval of Zepbound for OSA is also under review in the EU.
New Indications to Expand LLY’s Tirzepatide Label
Other than Zepbound, Lilly markets tirzepatide as Mounjaro for type II diabetes. Mounjaro and Zepbound have seen great success generating huge revenues for Lilly.
Lilly has also filed regulatory applications in the United States and EU to seek approval for tirzepatide for heart failure with preserved ejection fraction (HFpEF). A phase III cardiovascular outcome study is also ongoing.A phase II study in metabolic dysfunction-associated steatohepatitis (MASH) met its primary endpoint in 2024. Approval for these expanded indications can further boost tirzepatide’s sales.
Despite a short time on the market, Mounjaro and Zepbound have become key top-line drivers for Lilly in 2024, with demand rising rapidly.
However, quarter-over-quarter growth of Zepbound and Mounjaro in 2024 has been impacted by supply and channel dynamics. Mounjaro and Zepbound’s sales were hurt due to inventory issues in the third quarter. Nonetheless, Lilly is expanding its manufacturing capacity for Mounjaro and Zepbound in order to balance demand and supply. Since 2020, Lilly has committed more than $23 billion for manufacturing capacity for Zepbound and Mounjaro in the United States and Europe. Last week, the FDA removed Mounjaro and Zepbound from its shortage list after determining that Lilly’s supply is currently meeting or exceeding demand. All these efforts are expected to improve the supply of Mounjaro and Zepbound in future quarters.
Competition Heating Up in the Obesity Market
Zepbound faces strong competition from Novo Nordisk’s obesity drug, Wegovy, which includes an ingredient called semaglutide. Semaglutide is also approved as Ozempic pre-filled pen and Rybelsus oral tablet for type II diabetes. Novo Nordisk also faces periodic supply constraints and drug shortages of its semaglutide products. Wegovy is already approved to reduce cardiovascular risks. Novo Nordisk is also looking to expand Wegovy’s indication to patients with heart failure with preserved ejection fraction and obesity.
Several companies like Amgen (AMGN - Free Report) and Viking Therapeutics (VKTX - Free Report) are making rapid progress in the development of novel GLP-1-based candidates for obesity in their clinical pipeline.
Last month, Amgen announced 52-week top-line data from a phase II study on MariTide, its GIPR/GLP-1 receptor for obesity for obesity. The data showed that MariTide led to approximately 20% average weight loss over 52 weeks without reaching a weight loss plateau. Amgen began a phase II study on candidate in type II diabetes in the third quarter.
Amgen plans to conduct a broad phase III program on MariTide across obesity, obesity-related conditions and type-II diabetes.
AMGN and VKTX’s products can pose strong competition to Mounjaro/Zepbound and Ozempic/Wegovy in the future.
Image: Bigstock
Lilly's Zepbound Receives FDA Approval for Sleep Apnea
Eli Lilly and Company (LLY - Free Report) announced that the FDA has approved its popular obesity drug, Zepbound (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. OSA is a common sleep-related breathing disorder that causes repeated interruptions in breathing (apnea) or shallow breathing (hypopnea) during sleep. OSA marks the second indication for Zepbound. The drug was approved to treat obesity or overweight issues in November 2023.
With the approval, Zepbound becomes the first and only prescription drug approved for treating for adults with moderate-to-severe OSA and obesity.
LLY’s stock was up 1.4% on Friday. It is also up in-premarket trading on Monday in response to the new approval. Also, rival Novo Nordisk (NVO - Free Report) announced disappointing data from a late-stage study on its next-generation obesity drug, CagriSema, on Friday, which also pushed LLY’s stock up.
Lilly’s stock has risen 31.7% so far this year compared with an increase of 1.4% for the industry.
Image Source: Zacks Investment Research
More on the FDA Approval for LLY’s Zepbound for OSA
Zepbound’s approval for OSA was based on data from SURMOUNT-OSA phase III studies, which showed that patients not on positive airway pressure (PAP) therapy taking Zepbound experienced 25 fewer breathing disruptions per hour compared to five with placebo. In adults taking PAP therapy, Zepbound led to 29 fewer breathing disruptions per hour compared to six with placebo. In addition to improved OSA symptoms, in adults with PAP therapy, Zepbound also led to an average weight loss of 20%. The studies also showed that around 50% of the patients experienced such improvements with Zepbound that they no longer had symptoms associated with OSA after one year.
Lilly’s regulatory application seeking approval of Zepbound for OSA is also under review in the EU.
New Indications to Expand LLY’s Tirzepatide Label
Other than Zepbound, Lilly markets tirzepatide as Mounjaro for type II diabetes. Mounjaro and Zepbound have seen great success generating huge revenues for Lilly.
Lilly has also filed regulatory applications in the United States and EU to seek approval for tirzepatide for heart failure with preserved ejection fraction (HFpEF). A phase III cardiovascular outcome study is also ongoing.A phase II study in metabolic dysfunction-associated steatohepatitis (MASH) met its primary endpoint in 2024. Approval for these expanded indications can further boost tirzepatide’s sales.
Despite a short time on the market, Mounjaro and Zepbound have become key top-line drivers for Lilly in 2024, with demand rising rapidly.
However, quarter-over-quarter growth of Zepbound and Mounjaro in 2024 has been impacted by supply and channel dynamics. Mounjaro and Zepbound’s sales were hurt due to inventory issues in the third quarter. Nonetheless, Lilly is expanding its manufacturing capacity for Mounjaro and Zepbound in order to balance demand and supply. Since 2020, Lilly has committed more than $23 billion for manufacturing capacity for Zepbound and Mounjaro in the United States and Europe. Last week, the FDA removed Mounjaro and Zepbound from its shortage list after determining that Lilly’s supply is currently meeting or exceeding demand. All these efforts are expected to improve the supply of Mounjaro and Zepbound in future quarters.
Competition Heating Up in the Obesity Market
Zepbound faces strong competition from Novo Nordisk’s obesity drug, Wegovy, which includes an ingredient called semaglutide. Semaglutide is also approved as Ozempic pre-filled pen and Rybelsus oral tablet for type II diabetes. Novo Nordisk also faces periodic supply constraints and drug shortages of its semaglutide products. Wegovy is already approved to reduce cardiovascular risks. Novo Nordisk is also looking to expand Wegovy’s indication to patients with heart failure with preserved ejection fraction and obesity.
Several companies like Amgen (AMGN - Free Report) and Viking Therapeutics (VKTX - Free Report) are making rapid progress in the development of novel GLP-1-based candidates for obesity in their clinical pipeline.
Last month, Amgen announced 52-week top-line data from a phase II study on MariTide, its GIPR/GLP-1 receptor for obesity for obesity. The data showed that MariTide led to approximately 20% average weight loss over 52 weeks without reaching a weight loss plateau. Amgen began a phase II study on candidate in type II diabetes in the third quarter.
Amgen plans to conduct a broad phase III program on MariTide across obesity, obesity-related conditions and type-II diabetes.
AMGN and VKTX’s products can pose strong competition to Mounjaro/Zepbound and Ozempic/Wegovy in the future.
Lilly has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Eli Lilly and Company Price and Consensus
Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote