Vivus Likely to Present Qsiva to the EMA Again

In a recent conference call with their shareholders, Vivus Inc announced that they still had high hopes for Qsiva to become a successful weight loss product marketed in Europe. The text of the update can be read by clicking on this link. Although this announcement was expected by most experts who have followed the history of this treatment, it also re-ignited the old debates as to whether this is a suitable treatment for obesity. Here we consider the main controversies and their potential impact on Qsiva becoming licensed in Europe.

The weight loss treatment is well known in the US, where it has been regulated since 2012 under the name Qsymia. Since its inception, the treatment gained headlines for the risk associated with the use of it. While some studies pointed to cardiovascular risks other pointed to the importance of pregnant women ceasing to use it as soon as they became aware of their pregnancy (as it could lead to birth defects). Other studies suggested that using the treatment would have a negative impact on the central nervous system.

However, Vivus’s rebuttal to these concerns came from pointing to findings from clinical trials called the QUIP trials and CONQUERS trials. These trials complemented each other and their combined duration was 112 weeks. In this time, through investigations of about 4000 participants were conducted. Their key findings suggested that the treatment appeared efficacious and safe (if administered to appropriate populations and in relevant dosages).

This was subsequently re-examined by the European Medicines Agency (EMA), who yet again maintained that the treatment should not be marketed in the UK. Their main reasoning for this was that although the studies addressed the initial concerns, long-term effects were not known. Because of this, they concluded that the risks outweighed the benefits and so the treatment was not to be marketed in Europe. The full text can be read here.

Whilst it would appear that these statements would have addressed the main concerns from all the parties, some online articles suggested that the stricter regulations in Europe were coloured by a past scandal of the Mediator treatment. This argument however, never gained momentum.

So, with this in mind, it is worth asking whether there is a future for Qsiva in Europe? We believe that it is only a matter of time before it becomes approved and several online healthcare providers are already gearing up to sell product, which could in itself be a worry for Vivus as this is a concern for the EMA. Here is an example of one regulated website that is already publicising Qsiva – This can be looked at on several levels.

Firstly, since it was marketed in the US there were no new side-effects noticed among the patients. This may be due to strict screening procedures of the clinicians prescribing the treatment or due to its relatively recent marketing. Secondly, the reported side effects may have been inflated in studies of the active ingredients, as they did not consider the dosage of the active ingredients in Qsymia and how they may have interacted. Thirdly, the argument that treatments may have long-term side effects may be a valid one. However, many other commonly used treatments were used long before this could be established so it is not clear why the need to wait is specific to Qsymia. It could be argued that by denying this treatment to obese individuals, they are at risk of suffering long-term effects on their cardiovascular health by simply waiting. Lastly, it is worth pointing out that new studies are coming out that consistently point to more benefits than costs of using Qsiva for various patient groups.

Based on all of these arguments, we are keen to see whether EMA’s decision not to market Qsiva in Europe will remain the same.