Arena’s obesity treatment lorcaserin rejected by FDA
pharmafile | October 25, 2010 | News story | Sales and Marketing | Arena Pharma, Eisai, FDA, FDA complete response letter, lorcaserin, obesity
A new weight loss drug has been rejected by the FDA because of numerous concerns about side-effects and limited efficacy.
The US regulator took action over concerns after cancers were seen in animal studies of US pharma company Arena’s lorcaserin. The FDA’s Complete Response Letter (CRL) said the fact that the drug’s mode of action is as yet unidentified was another reason for its refusal.
Lorcaserin looks set to be the latest in a long line of weight loss treatments that have either been refused marketing approval or have been shown to cause serious side-effects after reaching the market.
Despite the damning appraisal of the drug, Arena and its marketing partner Eisai said they would continue negotiations with the FDA to try and resolve the problems.
The FDA said the weight loss efficacy of lorcaserin in overweight and obese individuals without type II diabetes is “marginal” and recommended Arena submit the final study report of the BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial.
The regulator also stated that if the companies cannot provide evidence to alleviate concerns about tumour findings in rats, it may demand new clinical trials be carried out.
The BLOOM-DM trial evaluated lorcaserin versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes mellitus. The trial is complete, and Arena expects to announce top-line results in the next few weeks and to have a completed study report by the end of the year.
The FDA said that even if the drug were approved, it would recommend putting lorcaserin in Schedule IV of the Controlled Substance Act, which would mean its use would be highly restricted.
Andrew McConaghie
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