A couple of months ago we reported that Orexigen would be
submitting an application for a marketing authorisation to the European
Medicines Agency for Contrave, its obesity medication. That submission has now
happened and the EMA will be accepting interim results from the company’s
cardiovascular outcomes study currently being conducted and known as the Light
Study. The concerns about cardiovascular risk are not immediately obvious but
this study was requested by the FDA as pre-condition for approval in the US.
Contrave contains two active ingredients that are already licensed
individually to treat addictions and depression. The combination of the two
work to inhibit appetite. The weight loss achieved in clinical trials was not
overly impressive but it did meet the minimum standards required of weight loss
medications; the only question was the safety of the medication.
In other weight loss news, the patent-holder of Qsiva has
requested information from the European Medicines Agency regarding the scientific
data they will require from the cardiovascular outcomes study being conducted
in the post-marketing environment in the US where Qsiva is being marketed as
Qsymia. It is our understanding that the
scientific advisory committee of the EMA recommended approval of Qsiva but the
EMA committee went against this recommendation. One of the objections was that
the medication may end up being taken by the wrong people, which is quite
frankly a preposterous position to take. All medications could potentially be
taken by people for whom they are not intended – that is why we have a system
of practitioner prescribing.
Based on the studies we have seen, it is our view that Qsiva
is the more effective medication but it remains to be seen whether or not its
safety profile established in clinical trials will be borne out in the
post-marketing environment.