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VIVUS Provides Update on Timing of European Decision for Qnexa(R)
Oral Hearing Scheduled for September 2012 Meeting of the CHMP
MOUNTAIN VIEW, Calif., June 5, 2012 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rescheduled the decision process on the Marketing Authorization Application (MAA) for Qnexa, an investigational drug for the treatment of obesity. In April, VIVUS submitted its response to the Day 180 List of Outstanding Issues from the CHMP, and was invited by the CHMP to participate in an oral hearing in order to provide additional explanations of the Day 180 response. An oral hearing is a customary part of the EMA approval process. VIVUS requested additional time to prepare for the oral hearing, and the CHMP has agreed to schedule the hearing in September 2012. The CHMP opinion on the Qnexa MAA is now expected following the September meeting.
"We appreciate the flexibility of the CHMP to work with us on the timing of the oral hearing and the scheduling in September," said Peter Tam, president of VIVUS. "We look forward to presenting to the CHMP in September, but are currently focused on working with the FDA ahead of the July 17, 2012 PDUFA and the potential Qnexa launch in the U.S. in the second half of this year."
Source: press release, 6/05/12. http://ir.vivus.com/releasedetail.cfm?ReleaseID=679994
VIVUS Files European Marketing Authorization Application for QNEXA® in the Treatment of Obesity
MOUNTAIN VIEW, Calif., Dec. 20, 2010 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA® (phentermine/topiramate) Controlled Release Capsules in the European Union (EU). The proposed indication in the EU is for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a mildly hypocaloric diet. If approved in the EU, QNEXA® could be recommended for obese adult patients (BMI ≥ 30 kg/m2), or overweight patients (BMI ≥ 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity).
Source: press release, 12/20/10. http://ir.vivus.com/releasedetail.cfm?ReleaseID=537928
|Qnexa(TM) Obesity||Endocrine and Metabolism||Obesity||Neurotransmitter modulation||Presynaptic neurons|
Mechanism of action: Qnexa(TM) has activity as both an appetite suppressant and satiety inducer. Qnexa is a combination of the drugs phentermine and topiramate. Phentermine is a member of the amphetamine class of drugs that act as neurotransmitter modulators. Topiramate is used as an anticonvulsant and has appetite suppressant side effects.
Phase of Development: Filed
Event Type: Regulatory EMA: CHMP Opinion (Estimate)
VIVUS Receives Formal Decision From CHMP
MOUNTAIN VIEW, Calif., Oct. 18, 2012 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that is has received the formal opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following their October 15-18 meeting. As expected, the CHMP recommended against approval of the Marketing Authorization Application (MAA) for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity in the European Union. The reasons for their decision were due to concerns over the potential cardiovascular and central nervous system effects associated with long-term use, teratogenic potential and use by patients for whom Qsiva is not indicated. The company currently intends to appeal this opinion and request a re-examination of the decision by the CHMP.
"The lack of effective pharmacologic treatments for obesity remains a high medical need for many patients in Europe," stated Peter Tam, VIVUS' president. "We are committed to getting Qsiva approved in Europe and will work closely with the new rapporteur and co-rapporteur to make this happen."
Source: press release, 10/18/12. http://ir.vivus.com/releasedetail.cfm?ReleaseID=714703
VIVUS Provides Update on the Review of the Qsiva Marketing Authorization Application
MOUNTAIN VIEW, Calif., Sept. 21, 2012 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that based on preliminary feedback from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the company expects an opinion recommending against approval of the Marketing Authorization Application (MAA) for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity. The formal decision from the CHMP is expected following their October 2012 meeting. If a negative recommendation is issued in October, and depending upon the nature of the objections, the company will either resubmit the MAA at a later date or appeal this decision and request a re-examination by the CHMP.
"We await the official decision and the formal report which should provide us specifics on any additional requirements leading to the approval of Qsiva in Europe," said Peter Tam, president of VIVUS. "We will work closely with the CHMP to address the Committee's concerns. VIVUS is committed to making this important medication available to obese patients in Europe."
About 50% of adult Europeans are obese or overweight and there are limited treatment options in Europe to address this high unmet medical need. Qsiva was approved by the FDA in July 2012 and was recently launched in the United States under the trade name Qsymia™. Qsiva was studied in over 3,500 patients over 56 weeks establishing it as a safe and effective treatment for obesity.
Source: press release, 9/21/12. http://ir.vivus.com/releasedetail.cfm?ReleaseID=708659