CHMP rejects Qsiva (Vivus Inc.,) as a treatment for Obesity - 21-Oct-2012

On 18 October 2012, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Qsiva (phentermine plus topiramate) from Vivus Inc., intended for the treatment of Obesity.

The CHMP noted that the main studies showed clinically relevant weight loss following treatment with Qsiva but had concerns about the medicine’s long-term effects on the heart and blood vessels, particularly due to the effects of phentermine, which is known to increase the heart rate but whose long-term effects are not clear. Secondly, there were concerns about the long-term psychiatric effects (depression and anxiety were reported in the studies) and cognitive effects (such as problems with memory and attention) related to the topiramate component of Qsiva. Topiramate is also known to be potentially harmful to the unborn baby if taken by pregnant women. The Committee noted that there was a high probability that, if approved, the medicine would not be used strictly for the intended patients. The applicant did propose measures to reduce this risk, but the measures were considered difficult to implement in practice.

The drug is FDA approved as Qsymia.