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Arena's lorcaserin a year out from next FDA review

 
• By Donna Young

Arena Pharmaceuticals and commercialization partner Eisai said it could be a year before they resubmit their marketing application to the US FDA for their embattled weight-loss drug lorcaserin, citing the need to complete additional animal studies and a small 10-patient volunteer trial after regulators rejected the drug on concerns that rat data showed an increase in tumours.

Arena Pharmaceuticals and commercialization partner Eisai said it could be a year before they resubmit their marketing application to the US FDA for their embattled weight-loss drug lorcaserin, citing the need to complete additional animal studies and a small 10-patient volunteer trial after regulators rejected the drug on concerns that rat data showed an increase in tumours.

The companies said it likely would be mid-2012 before the FDA makes another approval decision on the drug, which received a complete response letter in October.

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