Obesity drugs vie for approval as FDA panel backs lorcaserin
pharmafile | May 14, 2012 | News story | Research and Development, Sales and Marketing | Arena, Eisai, FDA, Qnexa, lorcaserin, obesity
An FDA panel has recommended Arena’s obesity drug lorcaserin, setting up a showdown with Vivus’ Qnexa.
Qnexa was recommended by an FDA panel in February and now both drugs will hope to become the first anti-obesity treatment approved in the US since Roche’s Xenical in 1999.
Both drugs were rejected by the FDA two years ago after safety concerns, but now Qnexa and lorcaserin could be on the US market by the end of the year.
But if approved, both drugs would most likely have to undergo follow-up studies on how the medicines affect the heart. Analysts says that both drugs should be making around $500 million in peak annual sales.
The FDA’s endocrinologic and metabolic drugs advisory committee voted 18 to 4, with 1 abstention, that lorcaserin outweighed the potential risks when used long-term in a population of overweight and obese individuals.
The drug has been developed by US, San Diego-based Arena in conjunction with Eisai.
Arena and Eisai are hoping that lorcaserin will gain a new licence for weight management, including weight loss and maintenance of weight loss, in patients who are obese, or patients who are overweight and have at least one weight-related co-morbid condition.
According to the US Centers for Disease Control and Prevention, two-thirds of American adults are overweight or obese.
Furthermore, the prevalence of obesity in the US more than doubled among adults from 1980 to 2010, meaning any new – and safe – obesity drug could be highly lucrative.
The FDA is expected to make its final decision on the lorcaserin by 27 June, and Qnexa by 17 July.
Ben Adams
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