) 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
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
Arena Pharmaceuticals, Inc.
) Belviq and
Novo Nordisk needs to bring new products to market considering that
Prandin is facing generic competition.
) 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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