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Novo Nordisk (NVO) Files for Ozempic's Label Expansion in US
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Novo Nordisk A/S (NVO - Free Report) announced that it has submitted a label expansion application to the FDA for the existing marketing authorization for Ozempicto include a new dose of 2.0 mg.
We note that Ozempic is currently approved in the United States in 0.5 mg and 1.0 mg doses for the treatment of type II diabetes in adults. In January 2020, the drug was approved in the United States for cardiovascular (CV) risk reduction in people with type II diabetes and established cardiovascular diseases.
Shares of the company have rallied 3.1% in the past year compared with the industry’s growth of 4.1%.
The submission is supported by results from the SUSTAIN FORTE study, which included 961 people with type II diabetes in need of treatment intensification. In the study, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared to semaglutide 1.0 mg. In the study, most people achieved the treatment target of HbA1c levels below 7%.
The company also submitted an application to the European Medicines Agency (EMA) for the same in December 2020.
With the 2.0 mg dose, more people with type II diabetes will be able to achieve the treatment target.
The FDA approved Ozempic once-daily pre-filled pen to improve glycemic control in type II diabetes patients in December 2017.
Label expansion of drugs will boost sales for the company.
Novo Nordisk has a strong presence in the diabetes care market with one of the broadest diabetes portfolios in the industry.
Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Alkermes Plc. (ALKS - Free Report) , Acorda Therapeutics Inc. and Alexion Pharmaceuticals Inc. . While Alkermes and Acordacarry a Zacks Rank #1 (Strong Buy), Alexion carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates have increased from 48 cents to 52 cents for 2021 over the past 60 days. Shares of the company have increased 12.9% in the past year.
Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.
Alexion’s earnings per share estimates have increased from $12.04 to $12.06 for 2020 and from $12.77 to $12.78 for 2021 over the past 60 days.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Novo Nordisk (NVO) Files for Ozempic's Label Expansion in US
Novo Nordisk A/S (NVO - Free Report) announced that it has submitted a label expansion application to the FDA for the existing marketing authorization for Ozempicto include a new dose of 2.0 mg.
We note that Ozempic is currently approved in the United States in 0.5 mg and 1.0 mg doses for the treatment of type II diabetes in adults. In January 2020, the drug was approved in the United States for cardiovascular (CV) risk reduction in people with type II diabetes and established cardiovascular diseases.
Shares of the company have rallied 3.1% in the past year compared with the industry’s growth of 4.1%.
The submission is supported by results from the SUSTAIN FORTE study, which included 961 people with type II diabetes in need of treatment intensification. In the study, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared to semaglutide 1.0 mg. In the study, most people achieved the treatment target of HbA1c levels below 7%.
The company also submitted an application to the European Medicines Agency (EMA) for the same in December 2020.
With the 2.0 mg dose, more people with type II diabetes will be able to achieve the treatment target.
The FDA approved Ozempic once-daily pre-filled pen to improve glycemic control in type II diabetes patients in December 2017.
Label expansion of drugs will boost sales for the company.
Novo Nordisk has a strong presence in the diabetes care market with one of the broadest diabetes portfolios in the industry.
Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Alkermes Plc. (ALKS - Free Report) , Acorda Therapeutics Inc. and Alexion Pharmaceuticals Inc. . While Alkermes and Acordacarry a Zacks Rank #1 (Strong Buy), Alexion carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates have increased from 48 cents to 52 cents for 2021 over the past 60 days. Shares of the company have increased 12.9% in the past year.
Acorda’s loss per share estimates have narrowed from $9.66 to $8.48 for 2020 and from $9.60 to $7.33 for 2021 over the past 60 days.
Alexion’s earnings per share estimates have increased from $12.04 to $12.06 for 2020 and from $12.77 to $12.78 for 2021 over the past 60 days.
Novo Nordisk AS Price
Novo Nordisk AS price | Novo Nordisk AS Quote
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>