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Novo Nordisk's Victoza Gets FDA Nod for Pediatric Patients

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Novo Nordisk A/S (NVO - Free Report) announced that the FDA has approved a label expansion of Victoza (liraglutide). The drug is now approved for the treatment of pediatric patients aged 10 years or older with type II diabetes. It is the only non-insulin drug approved for children other than metformin, which was approved for pediatric use in 2000.

In fact, the drug was approved by the FDA to treat adults with type II diabetes in 2010.

Victoza has now been proved to improve blood sugar control in pediatric patients with type II diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.

Type II diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels.

Shares of the company have increased 12% compared with the industry’s growth of 5.8%.

 

 

Victoza improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. GLP-1 is often found in insufficient levels in type II diabetespatients. Like GLP-1, Victoza slows digestion, prevents the liver from producing too much glucose, and helps the pancreas produce more insulin when needed.

The efficacy and safety of Victoza for reducing blood sugar in patients with type II diabetes were studied in several placebo-controlled trials in adults and one placebo-controlled trial with 134 pediatric patients aged 10 years or older for more than 26 weeks. The studies have shown that about 64% of patients in the pediatric study had a reduction in their hemoglobin A1c (HbA1c) below 7% while on Victoza compared to only 37% who achieved these results with placebo. 

Novo Nordisk’s top line is driven by strong performance of products like Victoza. The company continues to be the global market leader in the GLP-1 segment, with a 46.1% value market share. With this approval, sales of the company should rise further.

Novo Nordisk has a strong presence in the Diabetes care market, with a global value market share of 28.1%. Also, the company has strong presence in the total insulin market, with a global value market share of 46.7%.

However, Novo Nordisk is going through a rough patch, with several drugs in its portfolio losing patent protection. The company is also facing pricing pressure for some of its drugs.

Moreover, the diabetes market is already crowded with a number of drugs. Merck’s (MRK - Free Report) Januvia and Janumet (type II diabetes), Eli Lilly’s (LLY - Free Report) Trulicity (type II diabetes), and Sanofi’s (SNY - Free Report) Toujeo (type I and II diabetes) are already approved.

Zacks Rank

Novo Nordisk currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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