FDA Approves Label Expansion of Novo Nordisk's (NVO) Saxenda
Novo Nordisk A/S (NVO) announced that the FDA has approved an updated label for Saxenda (liraglutide) injection 3 mg. The Saxenda Injection is now approved for the treatment of obesity in adolescents (12-17 years) with a body weight above 60 kg and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater for adults, as an adjunct to a reduced-calorie diet and increased physical activity.
Shares of the company have increased 18.9% year to date compared with the industry’s 6.6% growth.
We note that Saxenda is already indicated in the United States for chronic weight management in adults with a BMI greater than or equal to 30 kg/m2, or 27 kg/m2 or higher with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.
We note that the approval for label expansion of Saxenda was supported by data from a phase III study, which investigated the effects of Saxendacompared to placebo for weight management in 251 adolescents (aged 12-18 years) living with obesity as an adjunct to lifestyle therapy. The primary endpoint was change from baseline in BMI Standard Deviation Score (SDS) at week 56. The data showed a significant reduction in BMI-SDS and reductions in BMI, mean body weight, as well as other weight-related endpoints versus placebo in adolescents with obesity when using Saxenda as an adjunct to lifestyle therapy.
A label expansion of the drug will lead to increased sales for the company.
We note that 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 from 28.4% to 29.2% over the past 12 months, driven by an improved global insulin market share and expansion of the GLP-1 segment.
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, Aptose Biosciences Inc. APTO and Alimera Sciences Inc. ALIM, 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.
Aptose’s loss per share estimates have narrowed from 77 cents to 69 cents for 2020 and from 85 cents to 81 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.
Novo Nordisk AS Price
Novo Nordisk AS price | Novo Nordisk AS Quote
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