The Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) recently did not recommend
the approval of
) weight-loss drug, Qsiva. The CHMP arrived at the decision at
its October 15-18 meeting.
ARENA PHARMA (ARNA): Free Stock Analysis
(ESALY): ETF Research Reports
OREXIGEN THERAP (OREX): Free Stock Analysis
VIVUS INC (VVUS): Free Stock Analysis Report
To read this article on Zacks.com click here.
The CHMP rendered a negative opinion due to concerns over the
potential cardiovascular and central nervous system effects
associated with the long-term use, teratogenic potential and use
by patients for whom Qsiva is not meant. Vivus intends to appeal
against the negative opinion. The company also intends to request
the CHMP to re-examine its negative opinion.
The negative opinion issued by the CHMP did not come as a
surprise. Last month, Vivus had announced that it expected the
CHMP to recommend against the approval of Qsiva in Europe. The
company's expectation was based on a preliminary feedback
provided by the CHMP.
We note the drug is already available in the US under the trade
name Qsymia. Qsymia was approved by the US Food and Drug
Administration (FDA) in July 2012. The FDA cleared Qsymia as an
adjunct to a healthy diet (low on calories) and increased
physical activity for chronic weight management in obese (Body
Mass Index, or BMI - 30 or more) or overweight (BMI - 27 or more)
adults suffering from at least one weight-related co-morbid
Neutral on Vivus
We currently have a Neutral recommendation on Vivus. The stock
carries a Zacks #3 Rank (Hold rating) in the short run. We note
that rival company
Arena Pharmaceuticals Inc.
) is preparing for the launch of its obesity drug Belviq along
with its partner
Eisai and Co Ltd.
), which got FDA approval in June 2012.
Orexigen Therapeutics, Inc.
) is also developing a candidate, Contrave, targeting the
lucrative obesity market.