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Novo Nordisk (NVO) Files for Ozempic's Label Expansion in US

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Novo Nordisk A/S NVO 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. ACOR and Alexion Pharmaceuticals Inc. ALXN. 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.


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