Home > Online Clinic News > Lorqess (Lorcaserin) Nears D-Day with FDA Panel

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by Robert MacKay, Tuesday, May 1, 2012 | Categories: Lorcaserin

Arena, the pharmaceutical company responsible for weight loss drug hopeful, Lorcaserin, might yet be the first weight loss drug treatment to be approved by the Food and Drug Administration (FDA) since Orlistat was licensed as the agency has delayed proceedings with the approval of Qnexa for three months. But will Arena have done enough to convince the FDA that Lorcaserin is safe enough to put on the market?

The pharmaceutical company is hoping that the agency will approve Lorcaserin, which will be marketed as Lorqess, despite the meagre 3% difference in weight loss reported between it and the weight loss reported among the placebo control group in phase III clinical trials. However, Lorcaserin did reach the minimum weight loss requirements in that participants lost 5% or more of their original body weights in year one.

It is said that the new drug application submitted by Arena included an explanation regarding the drug and tumours found in rats that had been administered with the drug during animal trials. So, if the panel and the FDA are happy with what the pharmaceutical company has produced in the way of disproving previous concerns regarding the drug’s potential side effects, then the agency may let this one through. We have not seen the details of the explanation relating to the tumours identified in rats but this would not be the first medication that had this effect on rodents but not on humans – we are diffident species after all!

An advisory panel meeting will take place on May 10th and we are set to hear about whether or not the drug is approved on June 27th. We will update after the advisory panel has reported next week.





 
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