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Teva Pharmaceutical seeks to market generic version of Victoza

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Teva Pharmaceutical Industries has filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Novo Nordisk’s Victoza, the company announced in a press release.

Victoza (liraglutide), a GLP-1 receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It was approved by the FDA in 2010.

Should the abbreviated new drug application be approved, Teva may be entitled to 180 days of generic market exclusivity.

In June, results from the Liraglutide Effect and Action in Diabetes — Evaluation of Cardiovascular Outcome Results (LEADER) trial demonstrated that patients with type 2 diabetes and a history of CVD assigned liraglutide therapy saw reduced risk for CV death, nonfatal MI and stroke vs. those assigned a placebo. The trial, conducted at 410 sites in 32 countries, showed that, over a mean of 3.8 years, the drug reduced risk for 3-point major adverse cardiac events by 13%, for all-cause death by 15% and for CV death by 22% vs. placebo, while reducing HbA1c and body weight.