FDA Panel to Review Novo Nordisk's Victoza 3mg - Analyst Blog

Novo Nordisk NVO announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled an Advisory Committee meeting on Sep 11, 2014, to discuss the new drug application (NDA) submitted by the company for Victoza (liraglutide 3 mg). The company is looking to get Victoza approved for the treatment of adults suffering from obesity (with or without comorbidities) and overweight adults with comorbidities such as hypertension, dyslipidemia, sleep apnea or type II diabetes.

Although the FDA is not bound to accept the recommendations of its Advisory Committee, it usually does so.

We note that Novo Nordisk had filed the NDA for Victoza for the treatment of obesity in Dec 2014. Victoza is also under regulatory process in the EU for the same indication. It is already approved as an adjunct to diet and exercise for the treatment of type II diabetes.

According to the FDA, more than one-third of the U.S. adult population currently suffers from obesity, a health condition that leads to a number of health issues such as high blood pressure, type II diabetes and high cholesterol.

Some drugs currently approved for the treatment of obesity are Roche's (RHHBY) Xenical, Arena Pharmaceuticals, Inc.'s ARNA Belviq and VIVUS Inc.'s VVUS Qsymia.

Novo Nordisk needs to bring new products to market considering that Prandin is facing generic competition.

Orexigen Therapeutics' OREX NB32 is also under FDA review for the treatment of obesity. A feedback is expected by Jun 10, 2014.

Novo Nordisk carries a Zacks Rank #3 (Hold). Vivus holds a Zacks Rank #2 (Buy).

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