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.