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FDA Finds No Link Between Obesity Drugs and Suicidal Thoughts
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The FDA, on Thursday, announced there is no evidence that diabetes and obesity drugs belonging to the popular glucagon-like peptide-1 receptor agonists (GLP-1 RAs) class of medicines cause suicidal thoughts or actions.
The GLP-1 segment is an important class of drugs for multiple cardiometabolic diseases and is gaining significant popularity. GLP-1 drugs work by mimicking the hormone GLP-1, resulting in weight loss, lowering hemoglobin A1c (HbA1c) and reducing cardiovascular risks. GLP-1 drugs are approved for treating type II diabetes and obesity.
Some GLP-1 drugs that the FDA has approved recently are Eli Lilly’s (LLY - Free Report) tirzepatide medicines, which include diabetes drug Mounjaro and newly launched weight loss medicine, Zepbound, and Novo Nordisk’s (NVO - Free Report) semaglutide medicines, Ozempic and Rybelsus for type II diabetes and Wegovy for obesity.
The FDA has, over the past several months, been studying reports that claim that GLP-1 drugs cause suicidal thoughts or actions in patients taking them. However, the information in the reports was limited and did not establish any clear relationship between the use of GLP-1 drugs and suicidal thoughts, said the FDA. It also reviewed some clinical studies, which did not show any such association. The FDA is not ruling out that a small risk of suicidal thoughts may exist and will conduct further evaluations. The labels of obesity drugs, Zepbound and Wegovy, already have warnings about the risk of suicidal thoughts and actions.
The GLP-1 segment is particularly attracting a lot of interest for the obesity indication. Obesity has become a global health problem as it can cause other diseases like heart disease, diabetes and stroke. This resulted in an exponential increase in demand for obesity medicines. Also, social media has somewhat hyped the benefits of these medications.
According to a Morgan Stanley report, the market for obesity drugs could reach $77 billion by 2030. Though supply issues may affect the sales growth of these drugs in the near term, with the obesity market gaining popularity, analysts expect sales to increase. A huge demand for obesity drugs for cosmetic use may be causing a supply shortage. Nonetheless, drugmakers are rushing to enter the lucrative market.
Lilly’s Zepbound was approved in November 2023 and launched in December. Until Zepbound was approved, Wegovy was the only GLP-1 receptor agonist approved for treating obesity. Despite supply challenges, Wegovy is seeing strong prescription trends and is generating impressive revenues and profits for Novo Nordisk. However, Wegovy is expected to face significant competition from Zepbound in 2024 as the latter is priced lower than Wegovy.
In August, Lilly acquired private biotech Versanis, adding the latter’s lead mid-stage obesity candidate, bimagrumab, to its portfolio. Bimagrumab has the potential to show better quality weight loss by reducing fat mass while preserving muscle mass in people who are obese or have obesity-related complications.
Shares of Lilly and Novo Nordisk have risen 75.8% and 56.5%, respectively, in the past year, compared with an increase of 14.8% for the industry.
Image Source: Zacks Investment Research
Amgen (AMGN - Free Report) also has an interesting GLP-1 receptor candidate in its pipeline called maridebart cafraglutide, which is being developed in phase II for obesity. Maridebart cafraglutide is an antibody-peptide conjugate that has a dual mechanism of action. It activates the GLP-1 receptor (GLP-1R) and inhibits the GIP receptor (GIPR). Amgen has another obesity candidate in the pipeline called AMG-786, which is in phase I development.
In November, AstraZeneca (AZN - Free Report) announced an exclusive new deal with China-based private biotech Eccogene to develop the latter’s once-daily, low-dose, orally available small molecule GLP-1RA ECC5004 for treating obesity, type-II diabetes and other cardiometabolic conditions.
Image: Bigstock
FDA Finds No Link Between Obesity Drugs and Suicidal Thoughts
The FDA, on Thursday, announced there is no evidence that diabetes and obesity drugs belonging to the popular glucagon-like peptide-1 receptor agonists (GLP-1 RAs) class of medicines cause suicidal thoughts or actions.
The GLP-1 segment is an important class of drugs for multiple cardiometabolic diseases and is gaining significant popularity. GLP-1 drugs work by mimicking the hormone GLP-1, resulting in weight loss, lowering hemoglobin A1c (HbA1c) and reducing cardiovascular risks. GLP-1 drugs are approved for treating type II diabetes and obesity.
Some GLP-1 drugs that the FDA has approved recently are Eli Lilly’s (LLY - Free Report) tirzepatide medicines, which include diabetes drug Mounjaro and newly launched weight loss medicine, Zepbound, and Novo Nordisk’s (NVO - Free Report) semaglutide medicines, Ozempic and Rybelsus for type II diabetes and Wegovy for obesity.
The FDA has, over the past several months, been studying reports that claim that GLP-1 drugs cause suicidal thoughts or actions in patients taking them. However, the information in the reports was limited and did not establish any clear relationship between the use of GLP-1 drugs and suicidal thoughts, said the FDA. It also reviewed some clinical studies, which did not show any such association. The FDA is not ruling out that a small risk of suicidal thoughts may exist and will conduct further evaluations. The labels of obesity drugs, Zepbound and Wegovy, already have warnings about the risk of suicidal thoughts and actions.
The GLP-1 segment is particularly attracting a lot of interest for the obesity indication. Obesity has become a global health problem as it can cause other diseases like heart disease, diabetes and stroke. This resulted in an exponential increase in demand for obesity medicines. Also, social media has somewhat hyped the benefits of these medications.
According to a Morgan Stanley report, the market for obesity drugs could reach $77 billion by 2030. Though supply issues may affect the sales growth of these drugs in the near term, with the obesity market gaining popularity, analysts expect sales to increase. A huge demand for obesity drugs for cosmetic use may be causing a supply shortage. Nonetheless, drugmakers are rushing to enter the lucrative market.
Lilly’s Zepbound was approved in November 2023 and launched in December. Until Zepbound was approved, Wegovy was the only GLP-1 receptor agonist approved for treating obesity. Despite supply challenges, Wegovy is seeing strong prescription trends and is generating impressive revenues and profits for Novo Nordisk. However, Wegovy is expected to face significant competition from Zepbound in 2024 as the latter is priced lower than Wegovy.
In August, Lilly acquired private biotech Versanis, adding the latter’s lead mid-stage obesity candidate, bimagrumab, to its portfolio. Bimagrumab has the potential to show better quality weight loss by reducing fat mass while preserving muscle mass in people who are obese or have obesity-related complications.
Shares of Lilly and Novo Nordisk have risen 75.8% and 56.5%, respectively, in the past year, compared with an increase of 14.8% for the industry.
Image Source: Zacks Investment Research
Amgen (AMGN - Free Report) also has an interesting GLP-1 receptor candidate in its pipeline called maridebart cafraglutide, which is being developed in phase II for obesity. Maridebart cafraglutide is an antibody-peptide conjugate that has a dual mechanism of action. It activates the GLP-1 receptor (GLP-1R) and inhibits the GIP receptor (GIPR). Amgen has another obesity candidate in the pipeline called AMG-786, which is in phase I development.
In November, AstraZeneca (AZN - Free Report) announced an exclusive new deal with China-based private biotech Eccogene to develop the latter’s once-daily, low-dose, orally available small molecule GLP-1RA ECC5004 for treating obesity, type-II diabetes and other cardiometabolic conditions.
While Novo Nordisk carries a Zacks Rank #2 (Buy), Lilly, Amgen and AstraZeneca have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.