European regulators have recommend Vivus' Qsiva (phentermine/topiramate ER) should not be approved due to concerns about the obesity drug's long-term cardiovascular safety.
Vivus had previously said it expected this negative decision from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), despite its summer approval in the US under the brand name Qsymia.
The drug was approved by the US Food and Drug Administration (FDA) just weeks after Arena Pharmaceutical/Eisai's Belviq (lorcaserin) gained approval as the first drug available for the treatment of obesity in more than a decade, but there appears to be greater reservations in Europe for new treatments in a therapy area where there have been several high profile drug safety issues.
Of particular concern for the EMA was the active ingredient phentermine, which the Agency said is “known to increase the heart rate but whose long-term effects are not clear”.
Concerns about the drug's psychiatric effects, such as depression and anxiety, as well as cognitive effects, including memory loss, were also highlighted by the EMA as barriers to its recommendation, while the ingredient topiramate has been associated with harm to unborn babies when taking by pregnant women.
In addition, the CHMP pointed out that Qsiva would not be used strictly for the intended patients, and that measures proposed by Vivus to reduce this risk were not feasible in practice.
Combined, these negatives were not thought to outweigh Qsiva's potential benefits, with trials demonstrating that two thirds of patients taking the drug, alongside dietary changes and exercise, were able to lose five per cent of their body weight over the course of a year.
Responding to this negative recommendation, Vivus said it intends to appeal the CHMP's opinion and request a re-examination of the decision.
"The lack of effective pharmacologic treatments for obesity remains a high medical need for many patients in Europe," said Peter Tam, Vivus' president.
“We are committed to getting Qsiva approved in Europe and will work closely with the new rapporteur and co-rapporteur to make this happen.”