EU regulators have signalled their reluctance to approve new drugs for obesity once again by asking for more data on Arena Pharmaceuticals’ Belviq.
Arena said the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has indicated the panel has “major objections” that prevent a recommendation for approval of Belviq (lorcaserin).
“We do not believe we can resolve the major objections related to the result of non-clinical studies prior to the CHMP’s issuance of its final opinion,” commented Arena’s head of global regulatory affairs Craig Audet on a conference call yesterday.
“We have therefore decided to withdraw the [application] and are evaluating the best approach for submitting at a later date,” he said, adding that the company will continue to pursue registration of the product in Europe.
The nature of the objections has not been disclosed. However, in 2010 the FDA rejected Arena’s first application for the drug, asking for more details on cancer observed in animal studies. Belviq was subsequently approved in the US in June 2012, becoming the first new obesity drug to reach the market there for 13 years.
At present it has yet to be launched as the Drug Enforcement Administration (DEA) is still consulting on its scheduling status. Arena chief executive Jack Lief said that, while the time taken to complete the scheduling has been “disappointing”, once the process is complete, marketing partner Eisai will be ready for an immediate launch into retail pharmacies.
The disappointment for Arena in Europe follows a similar knockback for Vivus with its Qsymia (phentermine/topiramate ER) obesity treatment, which failed to win CHMP backing last October. As is the case with Belviq, Qsymia had already been granted approval in the US.
Marketing applications for Belviq have also been filed in Switzerland – with feedback from Swissmedic expected in the summer – while Eisai has also filed the drug in Mexico and is preparing for applications in Canada and Brazil. Meanwhile, South Korean licensee Ildong Pharma will start clinical trials of the drug shortly.
Arena is also looking at combining Belviq with an older obesity drug (phentermine) and has asked for FDA input on a post-marketing trial design. In addition, it is considering combinations with diabetes treatment metformin and antipsychotic olanzapine, a drug which has a major issue with weight gain, said Lief.
Forecasts for the sales potential of the Belviq and Qsymia vary widely, but many analysts suggest blockbuster sales are likely given the dearth of effective pharmacological treatments for obesity. A number believe they can top $1bn apiece within three years of launch, and possibly reach as much as $2bn-$3bn a year at peak.