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US government health officials have said that an experimental diet drug produced minimal weight loss, while raising safety questions about its effects on the heart.
Arena Pharmaceuticals’ lorcaserin is one of three drugs racing to be the first new prescription weight loss pill approved by the US Food and Drug Administration (FDA) in more than a decade.
While lorcaserin’s weight loss results trail competitors, analysts have predicted it would win FDA approval thanks to a stellar safety profile.
However, in a review posted online, FDA scientists said the drug barely met the agency’s threshold for weight loss effectiveness and raised safety concerns about side effects, including heart valve disease and psychiatric problems.
Arena studied the drug in more than 7,000 obese and overweight patients. After one year, the average weight loss among lorcaserin patients was 5.8 pounds, compared with 2.5 pounds among patients taking a dummy pill.
That difference was enough to meet FDA’s effectiveness requirements “by a slim margin”, according to reviewers. Elsewhere, scientists described weight loss with the drug as “relatively low”.
The FDA will on Wednesday ask a panel of experts to assess lorcaserin’s effectiveness and safety. Specifically, panellists will be asked if the company should conduct more studies to rule out the possibility that its drug leads to heart valve disease.
The agency is not required to follow the panel’s advice, although it often does.
Copyright Press Association 2010