) recently announced that it expects the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) to recommend against the approval of its weight-loss drug,
Qsiva, next month. The company's expectation was based on a
preliminary feedback provided by the CHMP. The news impacted Vivus'
Vivus stated further in its press release that if its fears do
materialize then it might either resubmit the marketing
authorization application (MAA) for the drug to the EMA at a later
date or may ask for a re-examination of the CHMP's negative
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 condition.
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.
Just as the path leading to European approval is not expected to be
hiccup-free for the weight loss drug, US approval too did not come
easily. Vivus 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.
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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.
Qsymia was subsequently approved in July by the FDA. The drug was
launched in the US earlier this month.
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
Eisai and Co Ltd.
), which got FDA approval in June 2012.
Orexigen Therapeutics, Inc.
) is also developing a candidate, Contrave, targeting the lucrative