Novo Nordisk's Fiasp Gets EC Approval For Label Expansion

Novo Nordisk (CSE:NOVOb) A/S (NYSE:NVO) announced that the European Commission (EC) has approved the label expansion of its fast-acting insulin aspart, Fiasp, for the treatment of diabetes in adolescents and children aged one year or older. Initially, the drug was approved for the same indication but covered adults only.

Notably, Fiasp is also marketed in the United States for the treatment of adults with diabetes.

Shares of the company gained 14.5% year to date compared with the industry’s growth of 1.7%.

We note that Novo Nordisk has a strong presence in the Diabetes care market, with a global value market share of 28.3%. The company has one of the broadest diabetes portfolios in the industry. Solid performance from Tresiba, Victoza, Ozempic, Xultophy and Saxenda boosted sales in the second quarter of 2019.

The company is also making efforts to develop new treatments for diabetes, which is its core area of expertise. In July 2019, the EC granted marketing authorization to Esperoct for the treatment of adolescents (≥12 years of age) and adults with hemophilia. Novo Nordisk expects to launch Esperoct in the first European countries during the second half of 2019.

During the second quarter of 2019, the company initiated four late-stage studies with Ozempic (injectable semaglutide) and oral semaglutide in patients with type II diabetes and serious complications, including cardiovascular disease, diabetic retinopathy and chronic kidney disease.

The company is also diversifying into areas other than diabetes. In July 2019, Novo Nordisk and Gilead Sciences (NASDAQ:GILD) initiated a phase II proof-of-concept study combining the latter’s semaglutide and the former's cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the treatment of patients with nonalcoholic steatohepatitis (NASH).

Zacks Rank and Other Stocks to Consider

Novo Nordisk currently has a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the large-cap pharmaceutical sector include Roche Holding (SIX:ROG) AG (OTC:RHHBY) and Novartis (NYSE:NVS) . While Roche sports a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Roche’s earnings per share estimates increased from $2.41 to $2.50 for 2019 and from $2.44 to $2.57 for 2020 over the past 60 days. Share price of the company has risen 14.2% year to date.

Novartis’ earnings per share estimates increased from $5.01 to $5.15 for 2019 and from $5.56 to $5.73 for 2020 over the past 60 days. Share price of the company has gained 22.1% year to date.

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