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

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Novo Nordisk A/S (NVO - Free Report) announced that it has submitted a label expansion application to the European Medicines Agency (EMA) for the marketing authorization of Ozempic to include a new dose of 2.0 mg.

We note that Ozempic is currently approved in the EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults.

Shares of the company have rallied 23.8% year to date compared with the industry’s growth of 5.4%.

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.

With the 2.0 mg dose, more people with type 2 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. In January 2020, the drugwas approved in the United States for cardiovascular (CV) risk reduction in people with type II diabetes and established cardiovascular diseases.

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 Aerpio Pharmaceuticals Ltd. (ARPO - Free Report) , ASLAN Pharmaceuticals Ltd. (ASLN - Free Report) and Aptose Biosciences Inc. (APTO - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days. Shares of the company have increased 54% year to date.

ASLAN’s loss per share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days.

Aptose’s loss per share estimates have narrowed from 79 cents to 69 cents for 2020 and from 90 cents to 81 cents for 2021 over the past 60 days.

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