) recently announced that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA)
re-examined and confirmed its decision about not recommending the
approval of weight-loss drug, Qsiva. We note that earlier, in Oct
2012, the CHMP had rendered a negative opinion on the marketing
authorization application (MAA) for Qsiva.
The CHMP is concerned about the potential cardiovascular and
central nervous system effects associated with the long-term use,
teratogenic potential and misuse by patients for whom Qsiva is
not meant. The CHMP considers a pre-approval cardiovascular
outcomes trial to be essential for establishing the long-term
safety of Qsiva.
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 Jul 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
Though not unexpected, we are disappointed with the CHMP's
decision. The company is banking heavily on the drug for future
growth. We expect to gain more visibility on the drug's prospects
in the US once the company reports fourth quarter 2012 results on
Feb 25, 2013.
We remind investors that apart from Qsymia, another weight-loss
Arena Pharmaceuticals, Inc.'s
) Belviq, also received approval in the US last year.
Orexigen Therapeutics, Inc.
) is also developing a candidate, Contrave, targeting the
lucrative obesity market.
Vivus, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Biopharma companies that currently look more
) with a Zacks Rank #1 (Strong Buy).
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