Vivus Inc.
(
VVUS
) will have to wait an additional three months before the US Food
and Drug Administration (FDA) delivers a decision on the
approvability status of its lead pipeline candidate, Qnexa. The FDA
has extended Qnexa's target date to July 17, 2012 from April 17,
2012.
The news was not completely unexpected as Vivus had submitted
the Risk Evaluation and Mitigation Strategy (REMS) for Qnexa in the
first week of April. The REMS is a major amendment to the NDA and
consisted of proposed REMS materials. Since Vivus made the
submission within three months of the target date, the FDA had to
extend the PDUFA date in order to review the submission.
We note that Vivus resubmitted the new drug application (NDA)
for Qnexa in October 2011. The resubmission followed the company's
agreement with the FDA's Endocrine and Metabolic Division in
September 2011.
The company is seeking to get Qnexa approved for the treatment
of obesity, including weight loss and weight maintenance for obese
patients (BMI > 30 kg/m2), or overweight patients (BMI > 27
kg/m2), with weight-related co-morbidities such as hypertension,
type II diabetes, dyslipidemia, or central adiposity (abdominal
obesity).
We would like to remind the investors that the FDA's advisory
committee voted 20-2 in February 2012, for the approval of Qnexa on
the basis of a favorable benefit-risk profile of the candidate.
Vivus also filed a Marketing Authorization Application (
MAA
) with the European Medicines Agency (EMA) for Qnexa in December
2010. The Committee for Medicinal Products for Human Use (
CHMP
) issued a 180-Day letter of intent (LOI) requesting additional
information including risk minimization activities (the equivalent
of REMS in the US) to address various issues relating to
cardiovascular, neuropsychiatric and potential teratogenic effects
of Qnexa. Moreover, the letter requires Vivus to discuss the
benefit/risk profile of the different doses of Qnexa, the drug's
potential use in different patient populations, and the expected
long-term benefit of treatment with Qnexa. The company plans to
respond to the letter in the second quarter of 2012.
Obesity treatments currently in the market include orlistat,
sold by
Roche Holdings Ltd.
(
RHHBY
) as Xenical and by
GlaxoSmithKline
(
GSK
) as Alli.
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 expect
investors' focus to remain on Qnexa and avanafil's approval. Vivus
is seeking approval of avanafil for the treatment of erectile
dysfunction (
ED
). The FDA has set a target date of April 29, 2012 for the
drug.
GLAXOSMITHKLINE (
GSK
): Free Stock Analysis Report
VIVUS INC (
VVUS
): Free Stock Analysis Report
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