Vivus gets formal "No" from EMA panel on obesity drug

US drugmaker Vivus (Nasdaq: VVUS) revealed yesterday that is has received the formal opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) following its October 15-18 meeting, recommending, as expected, against approval of the Marketing Authorization Application (MAA) for Qsiva (phentermine/topiramate ER) for the treatment of obesity in the European Union. Vivus shares fell 2% to $20.70 in extended trading yesterday.

The reasons for the 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.

Last month, Vivus announced that, based on preliminary feedback from the CHMP, the company expected a negative opinion for Qsiva (The Pharma Letter September); which was approved by the USA’s Food and Drug Administration under the trade name Qsymia (TPL July 18) for the treatment of obesity and was launched in the USA last month (TPL September 19).