Following a dry spell of thirteen years, the US Food and Drug
Administration (FDA) approved two obesity drugs in the space of one
month. After approving
Arena Pharmaceuticals, Inc.
) Belviq last month, the FDA cleared
) weight-loss drug Qsymia, formerly known as Qnexa.
ARENA PHARMA (ARNA): Free Stock Analysis Report
OREXIGEN THERAP (OREX): Free Stock Analysis
VIVUS INC (VVUS): Free Stock Analysis Report
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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 overweight
(BMI >27) adults suffering from at least one weight-related
Management at Vivus stated that Qsymia is the first obesity drug to
be cleared as a combination therapy (once daily). Qsymia, a
combination of two drugs - phentermine and topiramate, is expected
to be launched by year-end. We note that FDA approval for Qsymia
was based on data from two randomized, double-blind,
placebo-controlled, phase III studies namely EQUIP and CONQUER.
Approval was granted with a Risk Evaluation and Mitigation Strategy
(REMS) and post-marketing requirements. The REMS will keep doctors
and pregnant ladies informed about the risks associated with Qsymia
to the unborn baby.
FDA approval gained in the second attempt
We note that success with Qsymia did not come easily to Vivus. The
company did not taste success in its first attempt to gain FDA
approval for Qsymia. The US regulatory body issued a complete
response letter (CRL) to the company in October 2010 in response to
the new drug application (NDA) submitted in December 2009. The FDA
accepted the re-submitted NDA in the final quarter of 2011 and
assigned a target date of April 17, 2012.
In February 2012, an advisory panel of the FDA voted 20-2 in favor
of approving Qsymia on the basis of a favorable risk-benefit
profile of the drug. The action date was pushed back by three
months following Vivus' submission of the REMS for Qsymia in the
first week of April. The REMS was a major amendment to the NDA. The
FDA approved the drug on the new action date of July 17.
We note that Qsymia is under review in the EU.
Neutral on Vivus
Even though the FDA approval of Qsymia is a huge boost for Vivus,
we prefer to remain on the sidelines with a neutral view on the
stock until the drug hits the market. Our long-term Neutral
recommendation is in line with the Zacks #3 Rank (Hold rating)
carried by the company in the short run. We note that
Orexigen Therapeutics, Inc.
) is also developing a candidate targeting the lucrative obesity