We previously reported that Vivus Inc did not feel confident about its obesity treatment, Qsiva (previously known as Qnexa) being approved for marketing in the EU. Therefore, we are not surprised to hear that Qsiva has now received a negative opinion from the European Medicines Agency.
Although the drug has been approved by the Food and Drug Administration (FDA) in the US under the name Qsymia, the current denial by the European Medicines Agency has been attributed to several concerns that are being argued to outweigh the benefits of the medication. All of these concerns (cardiovascular and psychiatric side effects) were raised in the US as well, and let us not forget that Qsymia was initially rejected by the FDA. The FDA ultimately got comfortable with the medication following further studies and a meta-analysis of previously published information.
The Committee for Medicinal Products for Human Use seems to have majored on the potential use of Qsiva by people for whom it is not intended but this could be said of many medications. Clearly there must be very strict prescription and supply guidelines for this medication and we believe that Vivus has put forward a risk mitigation strategy similar to the one used in the US.
Despite the negative outcome, Vivus has stated that it will appeal and request a re-examination of the decision. Given the very compelling clinical trial data that we have detailed on the Qsiva product page of our website, we would be very surprised if Qsiva is not ultimately approved for use in the EU. The dearth of effective weight loss treatments available for us to prescribe is very frustrating – both for us as doctors and for patients. It is all very well asking patients to go off and eat a different diet and take a bit of exercise but many have done this and failed. It is our view that the risks associated with Qsiva are more than outweighed by the benefits as far as obese patients are concerned. Our view would be different if we were talking about moderately overweight patients but it is up to doctors to ensure appropriate prescribing.