Vivus (VVUS) announced today that it is making a third attempt at gaining European approval for the anti-obesity drug Qsymia (known as Qsiva in Europe). Vivus has submitted to the European Medicines Agency (EMA) a request for scientific advice regarding use of a pre-specified interim analysis from the AQCLAIM cardiovascular outcomes trial (CVOT) to support the resubmission of the marketing authorization application (MAA) for approval.
"Our plan is on track to maximize the value of Qsiva in Europe and we believe that leveraging the AQCLAIM CVOT data is a prudent and scientifically sound approach, guided by our European senior advisors," said Seth Fischer, CEO of VIVUS. "We look forward to working with the European authorities to bring Qsiva to patients suffering from obesity and related comorbidities."
The AQCLAIM study is a randomized, double-blind, placebo-controlled multicenter clinical trial designed to assess the long-term treatment effect of Qsymia on the incidence of major adverse cardiovascular events in overweight and obese subjects with confirmed cardiovascular disease. This study is among the postmarketing requirements determined by the FDA in conjunction with the approval of Qsymia.
Essentially, the stance in Europe has been one that seems to try to mitigate risk as compared to the benefits offered. With minimal data on long-term impacts and effects, the EMA seems to have had a more cautious stance to anti-obesity medicines than the United States. Even Arena Pharmaceuticals (ARNA) Belviq has come across the more conservative stance of the EMA. Arena withdrew its application rather than face a rejection due to major concerns outlined by the agency. Another competitor, Orexigen (OREX), is in the application process with the anti-obesity drug Contrave.
Vivus is anticipating enrolling patients in the Aqclaim study in the next 6 months. The request for scientific advice from the EMA may allow the study to incorporate, and thus cover, the concerns of the European agency. In theory, this could pave the way to at least increasing the chance of an eventual approval.
In my opinion, the company with the fastest chance of European approval is Orexigen and Contrave. In fact, Contrave may have a faster path in Europe than it does in the United States. Vivus appears to be trying, and Arena seems to have placed Europe on a back burner of sorts.
For investors this news may seem welcomed, but it is really the first time we have heard anything material from the new CEO that took over only a month after Tony Zook resigned due to health issues. This European news is more long term for Vivus than near term. In the near term we once again have pretty flat sales growth for Qsymia in the United States. This past week sales, according to IMS Health, were just under 10,200. This points to about 9 consecutive weeks of essentially treading water on the sales figures. What is needed is stronger sales growth. Stalling at about 10,000 does not help illustrate longer term potential.
Additional disclosure: I have no position in Vivus or Orexigen