Home > Online Clinic News > Qsiva Again Denied a European License

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by Robert MacKay, Sunday, 24 February 2013 | Categories: Qnexa | Qsiva

Qsiva (formerly known as Qnexa and Qsymia in the US) has been denied a license by the European Medicines Agency following the appeal by Vivus. Vivus (the patent holder) requested a re-examination of the evidence and we believe that they put together a risk mitigation strategy similar to the one used in the US. This, however, did not impress the committee that decides which medications can be marketed in Europe. The committee has raised concerns about potential side effects but the fact is that both of the component medications are licensed in the European Union at the current time and the objections are to the actions of the components on a unilateral assessment; there is absolutely nothing to indicate that the dual therapy produced side effects not associated with the individual active ingredients. The objections are based on potential cardiovascular events related to phentermine and psychiatric side effects related to topiramate.

The evidence coming out of the US (where this medication is licensed as Qsymia) is that this treatment actually improves cardiovascular risk factors in patients who have successfully lost weight. The most recent update showed that patients being prescribed this medication recorded a medically significant drop in systolic blood pressure and a drop in non-HDL blood cholesterol. We continue to believe that for obese patients the benefits definitely outweigh the risks and this view was supported by the Scientific Advisory Group that provides guidance to the committee. The European Medicines Agency however appears to have based its risk assessment on the possibility that Qsiva will be used by patients for whom it is not intended. Surely that is what doctors are for – to make sure that medications are prescribed appropriately.

Medication cannot be the only answer to the obesity epidemic but it is part of the solution and there is a massive unmet clinical need in the EU that the EMA seems to be ignoring. We sincerely hope that Vivus takes this matter to the next level of appeal.





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