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Novo Nordisk (NVO) Falls on EMA Safety Review of Obesity Drugs
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Nono Nordisk’s (NVO - Free Report) GLP-1 receptor agonists, indicated for weight loss and treating type II diabetes, are under scrutiny by the European Medicine Agency ("EMA"). The EMA stated that its safety committee is conducting a review of obesity and diabetes care drugs, which include Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). Data on these drugs are being reviewed for the risk of suicidal thoughts and self-harm associated with their use.
Per the EMA, this review of the GLP-1 drugs was commenced by the Icelandic medicines agency, after receiving reports of suicidal thoughts and self-inflicted injuries in patients using liraglutide and semaglutide medicines. Authorities have reportedly identified about 150 reports of possible cases of self-injury and suicidal thoughts and are currently analyzing them.
The stock of the company was down 3% on Tuesday, following the dismal news. Year to date, shares of Novo Nordisk have gained 12.5% against the industry’s 1.6% decline.
Image Source: Zacks Investment Research
Currently, NVO is a key player in the diabetes and obesity space. Its semaglutide was initially approved to treat type II diabetes, under the trade name Ozempic. Later, the company received label expansion in the United States for once-weekly semaglutide injections to treat obesity or overweight in adults, under the brand name Wegovy.
The company is also currently evaluating a once-daily oral formulation of semaglutide for obesity indication in late-stage studies, with potential regulatory filings in the United States and EU, which is expected later this year.
Liraglutide was initially approved as a chronic weight management treatment option for adults in addition to a reduced-calorie diet and physical activity. Subsequently, in 2020, liraglutide’s label was expanded to include the treatment of obesity in adolescents (12-17 years).
The EMA has reported that the review of these drugs is being carried out in the context of a signal procedure. A signal here refers to safety information regarding a new adverse event or manifestation of a known adverse event that is potentially caused by the usage of a medicine. However, the EMA has clarified that if the presence of a signal is detected, it may not be necessarily caused by the usage of a particular medicine.
Notably, suicidal behavior is not currently listed as a side effect in the EU product information for any GLP-1 receptor agonists. The review of Ozempic, Saxenda and Wegovy started in July 2023 and has now been extended to include other GLP-1 receptor agonists. A final statement from the EMA is expected in November 2023.
Other key players in the GLP-1 market include pharma bigwigs like Eli Lilly (LLY - Free Report) and Pfizer (PFE - Free Report) .
In June 2023, Lilly completed the regulatory submission seeking label expansion for its dual GIP/GLP-1-RA drug, tirzepatide, to treat obesity or overweight in adults. A final decision is expected by the end of 2023. Data from one late-stage study (SURMOUNT-1), released last year, showed that treatment with tirzepatide led to mean weight reduction of up to 22.5% in patients without diabetes. Also, data from a second late-stage study (SURMOUNT-2) showed that tirzepatide treatment achieved mean reduction up to 15.7% in patients with type II diabetes.
Like Eli Lilly, Pfizer is also evaluating pipeline candidates for obesity. In May 2023, Pfizer reported positive data from the phase II study of its oral type II diabetes candidate, danuglipron. Per the data readout, danuglipron helped patients lose weight faster than Novo Nordisk’s popular diabetes weekly injection, Ozempic. If danuglipron is successful in further studies and eventually approved, it can enjoy strong demand trends as the demand for weight loss drugs is huge and rising. Also, danuglipron is an oral pill compared with weekly injections with Ozempic/Wegovy, which is an easier-to-use formulation.
Subject to the approval of their respective drugs, both Lilly and Pfizer have the potential to provide serious competition to Novo Nordisk and challenge its superiority in the diabetes and obesity care market.
In a separate press release, Reuters claimed that only about one-third of patients receiving Wegovy therapy continued treatment with the drug a year later, amidst growing healthcare costs for the group of patients on which the observation was made. Reuters reported this anomaly after receiving an analysis of U.S. pharmacy claims. Per Reuters, after starting the medication, treatment costs with Wegovy or a similar drug increase by almost 59% over the course of a year, which is rising a serious affordability issue, especially when any improvement in health and subsequent reduction in medical costs is not likely to occur quickly.
In the past 90 days, the Zacks Consensus Estimate for AbbVie’s 2023 earnings per share has increased from $10.97 to $10.99. During the same period, the estimate for AbbVie’s 2024 earnings has increased from $11.01 to $11.04. Year to date, shares of ABBV have lost 16.1%.
ABBV beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 1.78%.
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Novo Nordisk (NVO) Falls on EMA Safety Review of Obesity Drugs
Nono Nordisk’s (NVO - Free Report) GLP-1 receptor agonists, indicated for weight loss and treating type II diabetes, are under scrutiny by the European Medicine Agency ("EMA"). The EMA stated that its safety committee is conducting a review of obesity and diabetes care drugs, which include Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). Data on these drugs are being reviewed for the risk of suicidal thoughts and self-harm associated with their use.
Per the EMA, this review of the GLP-1 drugs was commenced by the Icelandic medicines agency, after receiving reports of suicidal thoughts and self-inflicted injuries in patients using liraglutide and semaglutide medicines. Authorities have reportedly identified about 150 reports of possible cases of self-injury and suicidal thoughts and are currently analyzing them.
The stock of the company was down 3% on Tuesday, following the dismal news. Year to date, shares of Novo Nordisk have gained 12.5% against the industry’s 1.6% decline.
Image Source: Zacks Investment Research
Currently, NVO is a key player in the diabetes and obesity space. Its semaglutide was initially approved to treat type II diabetes, under the trade name Ozempic. Later, the company received label expansion in the United States for once-weekly semaglutide injections to treat obesity or overweight in adults, under the brand name Wegovy.
The company is also currently evaluating a once-daily oral formulation of semaglutide for obesity indication in late-stage studies, with potential regulatory filings in the United States and EU, which is expected later this year.
Liraglutide was initially approved as a chronic weight management treatment option for adults in addition to a reduced-calorie diet and physical activity. Subsequently, in 2020, liraglutide’s label was expanded to include the treatment of obesity in adolescents (12-17 years).
The EMA has reported that the review of these drugs is being carried out in the context of a signal procedure. A signal here refers to safety information regarding a new adverse event or manifestation of a known adverse event that is potentially caused by the usage of a medicine. However, the EMA has clarified that if the presence of a signal is detected, it may not be necessarily caused by the usage of a particular medicine.
Notably, suicidal behavior is not currently listed as a side effect in the EU product information for any GLP-1 receptor agonists. The review of Ozempic, Saxenda and Wegovy started in July 2023 and has now been extended to include other GLP-1 receptor agonists. A final statement from the EMA is expected in November 2023.
Other key players in the GLP-1 market include pharma bigwigs like Eli Lilly (LLY - Free Report) and Pfizer (PFE - Free Report) .
In June 2023, Lilly completed the regulatory submission seeking label expansion for its dual GIP/GLP-1-RA drug, tirzepatide, to treat obesity or overweight in adults. A final decision is expected by the end of 2023. Data from one late-stage study (SURMOUNT-1), released last year, showed that treatment with tirzepatide led to mean weight reduction of up to 22.5% in patients without diabetes. Also, data from a second late-stage study (SURMOUNT-2) showed that tirzepatide treatment achieved mean reduction up to 15.7% in patients with type II diabetes.
Like Eli Lilly, Pfizer is also evaluating pipeline candidates for obesity. In May 2023, Pfizer reported positive data from the phase II study of its oral type II diabetes candidate, danuglipron. Per the data readout, danuglipron helped patients lose weight faster than Novo Nordisk’s popular diabetes weekly injection, Ozempic. If danuglipron is successful in further studies and eventually approved, it can enjoy strong demand trends as the demand for weight loss drugs is huge and rising. Also, danuglipron is an oral pill compared with weekly injections with Ozempic/Wegovy, which is an easier-to-use formulation.
Subject to the approval of their respective drugs, both Lilly and Pfizer have the potential to provide serious competition to Novo Nordisk and challenge its superiority in the diabetes and obesity care market.
In a separate press release, Reuters claimed that only about one-third of patients receiving Wegovy therapy continued treatment with the drug a year later, amidst growing healthcare costs for the group of patients on which the observation was made. Reuters reported this anomaly after receiving an analysis of U.S. pharmacy claims. Per Reuters, after starting the medication, treatment costs with Wegovy or a similar drug increase by almost 59% over the course of a year, which is rising a serious affordability issue, especially when any improvement in health and subsequent reduction in medical costs is not likely to occur quickly.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
Zacks Rank and Stock to Consider
Novo Nordisk currently has a Zacks Rank #3 (Hold).
A better-ranked stock in the same industry is AbbVie (ABBV - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for AbbVie’s 2023 earnings per share has increased from $10.97 to $10.99. During the same period, the estimate for AbbVie’s 2024 earnings has increased from $11.01 to $11.04. Year to date, shares of ABBV have lost 16.1%.
ABBV beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 1.78%.