Setback comes despite US approval for Qsiva/Qsymia
Vivus has said it is fully expecting to have its application to market obesity drug Qsiva rejected by the Committee for Medicinal Products for Human Use (CHMP) in the EU but will not give up on the programme.
Qsiva is a combination of phentermine and topiramate and is already on the market under the Qsymia trade name in the US, where it was approved by the FDA in July.
The situation is very different in Europe, however, with the CHMP expected to issue a negative opinion on Vivus' application when it convenes to discuss it in October.
The nature of the committee's reservations has not been disclosed by the company, but it is notable that the FDA extended its review time for the drug by three months in order to assess a Risk Evaluation and Mitigation Strategy (REMS) for Qsymia, which should not be used in pregnancy or by patients with heart disease, glaucoma or hyperthyroidism on safety grounds.
"If a negative recommendation is issued in October - and depending upon the nature of the objections - the company will either resubmit the [application] at a later date or appeal this decision and request a re-examination by the CHMP," it said in a statement.
Qsymia is the second weight-loss drug to be approved for marketing in the US recently, with Arena Pharmaceutical/Eisai's Belviq (lorcaserin) becoming the first new drug to be registered there for obesity in 13 years.
Prior to the approval of Belviq and Qsymia the only approved medicine on the market for obesity was Roche's lipase inhibitor Xenical (orlistat), which has seen its use limited by gastrointestinal side effects.
Qsymia has only just been made available in the US so there is as yet no sense of how sales will build. Vivus has been concentrating on manufacturing with its partner Catalent and is rolling out the product with the support of contract sales organisation PDI.
Vivus said that around 50 per cent of Europeans are obese or overweight, and there are limited treatment options available for them.
"We await the official decision and the formal report which should provide us specifics on any additional requirements leading to the approval of Qsiva in Europe," said Vivus' president Peter Tam.