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Novo Nordisk (NVO) Gets FDA Nod for Ozempic's Label Expansion
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Novo Nordisk A/S (NVO - Free Report) announced that the FDA has approved its diabetes medicine, Ozempic (once-weekly semaglutide subcutaneous injection) as a 2.0 mg dose for the treatment of adults with type II diabetes.
Following the latest nod, Ozempic is now approved at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type II diabetes in adults in the United States.
Ozempic is also indicated to reduce the risk of major cardiovascular events like heart attack, stroke or death in adult patients with type II diabetes and who have a known heart disease.
The FDA nod was based on data from the SUSTAIN FORTE study, which showed that treatment with semaglutide 2.0 mg led to a statistically significant and superior reduction in blood glucose (sugar) levels compared to semaglutide 1.0 mg at week 40.
Apart from the United States, Ozempic 2.0 mg is also approved in the European Union, Canada and Switzerland.
Shares of Novo Nordisk have dipped 3.7% so far this year against the industry’s increase of 2.5%.
Image Source: Zacks Investment Research
Semaglutide is presently approved by its trade name, Ozempic, as a once-daily pre-filled pen to improve glycemic control in type II diabetes patients. Meanwhile, oral semaglutide is marketed in the United Sates, the EU and other countries under the brand name Rybelsus for treating type II diabetes as an adjunct to diet and exercise for adults with uncontrolled conditions.
In June 2021, the FDA approved semaglutide as a weekly 2.4 mg injection for weight management in people with obesity. The GLP-1 product is marketed under the brand name Wegovy for chronic weight management in adults with obesity (initial BMI≥30 kg/m2) or who are overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity, such as high blood pressure, type II diabetes or high cholesterol.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has also rendered a positive opinion on, and recommended marketing authorization to Wegovy, a once-weekly semaglutide 2.4 mg injection for chronic weight management in adults with obesity.
Novo Nordisk is also evaluating semaglutide in phase III studies for Alzheimer’s disease and non-alcoholic steatohepatitis or NASH.
Novo Nordisk has a strong presence in the diabetes care market, with one of the broadest diabetes portfolios in the industry. The company has improved its global diabetes value market share over the past 12 months from 29.3% to 30.1%, driven by strong performance of its portfolio.
Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank of #3 (Hold). Better-ranked stocks in the healthcare sector include Innoviva, Inc. (INVA - Free Report) , Collegium Pharmaceutical, Inc. (COLL - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) . While Innoviva and Collegium Pharmaceutical sport a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’s earnings estimates have been revised 20.5% upward for 2022 and 27.9% upward for 2023 over the past 60 days. The INVA stock has rallied 12.3% year to date.
Earnings of Innoviva surpassed estimates in each of the trailing four quarters.
Collegium Pharmaceutical’s earnings estimates have been revised 51.9% upward for 2022 and 66.2% upward for 2023 over the past 60 days. The COLL stock has gained 5.4% year to date.
Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Vertex’s earnings estimates have been revised 1.2% upward for 2022 and 0.1% upward for 2023 over the past 60 days. The VRTX stock has increased 16.4% year to date.
Earnings of Vertex surpassed estimates in each of the trailing four quarters.
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Novo Nordisk (NVO) Gets FDA Nod for Ozempic's Label Expansion
Novo Nordisk A/S (NVO - Free Report) announced that the FDA has approved its diabetes medicine, Ozempic (once-weekly semaglutide subcutaneous injection) as a 2.0 mg dose for the treatment of adults with type II diabetes.
Following the latest nod, Ozempic is now approved at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type II diabetes in adults in the United States.
Ozempic is also indicated to reduce the risk of major cardiovascular events like heart attack, stroke or death in adult patients with type II diabetes and who have a known heart disease.
The FDA nod was based on data from the SUSTAIN FORTE study, which showed that treatment with semaglutide 2.0 mg led to a statistically significant and superior reduction in blood glucose (sugar) levels compared to semaglutide 1.0 mg at week 40.
Apart from the United States, Ozempic 2.0 mg is also approved in the European Union, Canada and Switzerland.
Shares of Novo Nordisk have dipped 3.7% so far this year against the industry’s increase of 2.5%.
Image Source: Zacks Investment Research
Semaglutide is presently approved by its trade name, Ozempic, as a once-daily pre-filled pen to improve glycemic control in type II diabetes patients. Meanwhile, oral semaglutide is marketed in the United Sates, the EU and other countries under the brand name Rybelsus for treating type II diabetes as an adjunct to diet and exercise for adults with uncontrolled conditions.
In June 2021, the FDA approved semaglutide as a weekly 2.4 mg injection for weight management in people with obesity. The GLP-1 product is marketed under the brand name Wegovy for chronic weight management in adults with obesity (initial BMI≥30 kg/m2) or who are overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity, such as high blood pressure, type II diabetes or high cholesterol.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has also rendered a positive opinion on, and recommended marketing authorization to Wegovy, a once-weekly semaglutide 2.4 mg injection for chronic weight management in adults with obesity.
Novo Nordisk is also evaluating semaglutide in phase III studies for Alzheimer’s disease and non-alcoholic steatohepatitis or NASH.
Novo Nordisk has a strong presence in the diabetes care market, with one of the broadest diabetes portfolios in the industry. The company has improved its global diabetes value market share over the past 12 months from 29.3% to 30.1%, driven by strong performance of its portfolio.
Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank of #3 (Hold). Better-ranked stocks in the healthcare sector include Innoviva, Inc. (INVA - Free Report) , Collegium Pharmaceutical, Inc. (COLL - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) . While Innoviva and Collegium Pharmaceutical sport a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’s earnings estimates have been revised 20.5% upward for 2022 and 27.9% upward for 2023 over the past 60 days. The INVA stock has rallied 12.3% year to date.
Earnings of Innoviva surpassed estimates in each of the trailing four quarters.
Collegium Pharmaceutical’s earnings estimates have been revised 51.9% upward for 2022 and 66.2% upward for 2023 over the past 60 days. The COLL stock has gained 5.4% year to date.
Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Vertex’s earnings estimates have been revised 1.2% upward for 2022 and 0.1% upward for 2023 over the past 60 days. The VRTX stock has increased 16.4% year to date.
Earnings of Vertex surpassed estimates in each of the trailing four quarters.