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Novo Nordisk (NVO) Files for Semaglutide Label Expansion in EU

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Novo Nordisk A/S (NVO - Free Report) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for subcutaneous Ozempic (semaglutide) 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1) analog for weight management. The company is seeking approval for the treatment of adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2)with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity. Obesity is a chronic disease that requires long-term management. 

In December 2020, the company submitted a new drug application (NDA) to the FDA for subcutaneous semaglutide 2.4 mg, analogue for chronic weight management.

Shares of the company have rallied 29.5% year to date compared with the industry’s growth of 6.8%.

We note that 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.

In September 2019, the FDA approved semaglutide in a tablet form, which is marketed under the brand name, Rybelsus. It is approved as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. The drug is off to a good start in the United States. It is the first approved glucagon-like peptide-1 (GLP-1) receptor agonist in a tablet form.

The submission is based on the results from the STEP phase IIIa program, which included more than 4,500 adults with obesity or overweight. The STEP program demonstrated that people with obesity treated with once-weekly semaglutide 2.4 mg achieved a statistically significant and superior reduction in body weight compared to placebo. A weight loss of 15-18% was reported for people treated with semaglutide 2.4 mg in people without diabetes in STEP 1, 3 and 4 programs. Once-weekly semaglutide 2.4 mg appeared to have a safe and well-tolerated profile.

Label expansion of drugs will boost sales.

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 Alimera Sciences Inc. (ALIM - 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.

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.

Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.


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