Shares of Vivus, Inc. (VVUS: Quote) are dropping 11 percent in early deals on Friday after the biopharmaceutical company announced that it expects European regulators to recommend against approving the Marketing Authorization Application (MAA) for its blockbuster obesity drug Qsiva.
The company said the disclosure is based on the preliminary feedback from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
However, the formal decision on the MAA from the CHMP is expected after their October 2012 meeting. The company noted that it will either resubmit the MAA or appeal against the decision and request a re-examination, based on the nature of the objections raised 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. 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," President Peter Tam said in a statement.
Obesity, a public health epidemic, is growing at an alarming rate. The company noted that as more than 50 percent adult Europeans are obese or overweight, this drug will boost the treatment options and address the significantly unmet medical need.
Qsiva or phentermine and topiramate extended-release, capsules CIV are indicated for use in adults who are obese or overweight with at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The drug is supplementary to a reduced-calorie diet and increased physical activity.
Qsiva was studied in over 3,500 patients over 56 weeks establishing it as a safe and effective treatment for obesity.
Qsiva was recently launched in the U.S. under the trade name Qsymia after it was approved by the U.S. Food and Drug Administration in mid-July 2012. It became only the second obesity drug to be approved by the FDA in thirteen years, and the first ever once daily combination treatment.
Qsymia, formerly known as Qnexa, has been approved for use in adults who are obese or overweight with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
In the U.S. also the blockbuster obesity drug faced difficulty in gaining approval. The FDA had in April deferred its decision on the Qsymia New Drug Application that was resubmitted in October 2011, and set an action date of July 17.
The FDA initially rejected Qsymia in October 2010, citing potential cardiovascular problems and more chances of cleft lips in children born to women who conceive while taking the drug. Mountain View, California-based Vivus then resubmitted Qsymia with longer-term data and analyzes.
Qsymia approval came just a fortnight after the FDA finally approved Arena Pharmaceuticals, Inc's (ARNA) Belviq or Lorcaserin as the first new drug therapy in nearly thirteen years to treat obesity that is assuming alarming proportions.
In Friday's regular trading session, VVUS is currently trading at $21.07, down $2.65 or 11.17% on a volume of 3.16 million shares.
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by RTT Staff Writer
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