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Novo Nordisk's Victoza Gets FDA Nod for Label Expansion

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Novo Nordisk A/S’ (NVO - Free Report) shares gained 1.1% on Friday after it announced that the FDA has approved the label expansion of Victoza. The drug is now approved as a treatment to reduce the risk of major adverse cardiovascular (CV) events including heart attack, stroke and CV death, in adults with type II diabetes and established CV disease.

Victoza is a once-daily human glucagon-like peptide-1 (GLP-1) analogue approved for the treatment of type II diabetes in adults. The drug is one of the main revenue contributors for the company with sales of $1.85 billion in the first half of 2017.

Novo Nordisk’s shares have outperformed the industry year to date. The stock rallied 28.7% compared with the industry’s gain of 10.9%, over the same time frame.

We note that the FDA’s approval was based on data from the pivotal LEADER study on CV outcomes, which evaluated the drug in more than 9,300 people with type II diabetes at high risk of major CV events. The study evaluated the drug in combination with standard-of-care over a period of up to five years. The data from the study demonstrated that Victoza significantly reduced the risk of CV death. The drug lowered the risk of non-fatal heart attack or non-fatal stroke by 13% compared to placebo and showed an absolute risk reduction of 1.9%.

Per one study, CV disease is a leading cause for death in diabetic patients. With the addition of new indication to its label, Victoza is expected to bring in more revenues as it can now be prescribed for diabetes medication that also reduces the patient's CV risk.

However, last year the FDA approved Eli Lilly and Company’s (LLY - Free Report) label expansion for the diabetes drug, Jardiance, to include CV risk reduction data. The drug with the updated label has already been launched in January 2017, which increases competition for Victoza.

Moreover, other companies like Merck & Co., Inc. (MRK - Free Report) and AstraZeneca plc (AZN - Free Report) are also developing their drug for the same indication. Notably, Merck was denied approval by the FDA in April 2017 to include CV outcomes data from the TECOS study on the labels of Januvia. Also, AstraZeneca’s Bydureon failed to reduce CV risk in a phase IIIb/IV CV outcomes study, EXSCEL.

Novo Nordisk A/S Price and Consensus


Novo Nordisk A/S Price and Consensus | Novo Nordisk A/S Quote

Novo Nordisk currently has 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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