Vivus faced a major setback yesterday when a European Medicines Agency (EMA) committee upheld its earlier decision to reject the company’s obesity drug candidate Qsiva.
The Committee for Medicinal Products for Human Use (CHMP) delivered a negative verdict on the company’s marketing application for Qsiva (phentermine/topiramate) last October, despite approval of the drug by the US FDA earlier in the year under the Qsymia brand name.
Vivus had asked the CHMP to re-examine its earlier decision, which was based on concerns about potential cardiovascular and central nervous system (CNS) with the combination therapy, but the panel has retained its position and said a cardiovascular safety trial must be carried out before Qsiva can be approved.
“Despite the positive recommendation of CHMP’s own Scientific Advisory Group (SAG) and the high unmet medical need in obese patients, a majority of CHMP members have failed to recognise the importance of making this treatment option available,” commented Vivus’ president Peter Tam.
Tam noted this is particularly disappointing for obese patients whose only effective intervention is currently surgery, adding that a phase III trial of the drug enrolled 4,500 patients over two years and established the drug as a safe and effective treatment.
The FDA did ask the company to develop a risk evaluation and mitigation strategy (REMS) for Qsymia to help ensure its safe use, as the drug is contraindicated for use in pregnancy or in patients with heart disease, glaucoma or hyperthyroidism.
Vivus has yet to report audited sales figures for Qsymia in the US, which was launched on September 17 through a controlled mail-order distribution system as a condition of the REMS – although the company suggested it had sold around $350,000-worth of product in the first month after launch.
Vivus has since filed a modified REMS with the FDA in a bid to broaden the distribution network into selected retail pharmacies, and is due to present audited results on 2012 sales at its annual results presentation next Monday.
Qsymia’s US approval came shortly after that of a rival obesity drug for obesity from Arena Pharmaceutical/Eisai – Belviq (lorcaserin) – with the two products ending a 13-year drought for new therapies.
And Belviq too may succumb to caution on the part of the CHMP. Last month, Arena said the committee had asked for more data on the safety profile of the drug, specifically with regard to heart valve issues, CNS side effects and tumours identified during animal studies.