Weight Loss Drug Denied A License-5603

October 21st, 2010
Weight Loss Drug Denied A License-5603

The United States Food and Drug Administration (FDA) refused a license for a latest weight-loss drug. The drug in question – Lorcaserin – was deemed not yet ready for approval.

It seems the FDA has concerns about Lorcaserin’s effectiveness and its potential risk in increasing cancer in users. Apparently, there were higher than normal cases of cancer development in clinical trials.

This decision is the latest in a number of decisions taken by the FDA regarding weight-loss medications. The FDA believes that many of the new pharmaceutical concoctions are not as effective as the companies manufacturing the drugs maintain. This is important when it’s realised one in three adults are classed as clinically obese.

Lorcaserin is made by Arena Pharmaceuticals in San Diego in partnership with another company Eisai Co. Trials carried out were published in the New England Journal of Medicine, and appeared to show two-thirds of patients lost around 5% of their body weight after taking the drug. Another third lost 10% while the average actual weight loss was 17 to 18 pounds.

The drug was also tested recently on Type 2 diabetics, many of whom are prone to obesity. These results are due to be released shortly.

While obviously disappointed with the FDA’s response, Arena Pharmaceutical’s president and chief executive, Jack Lief is still hopeful and upbeat that the company can address the FDA’s concerns. He told reporters recently: “This is an important step for us toward the FDA’s approval of Lorcaserin.”

Lorcaserin is not the only weight-loss drug to have been refused a license by the FDA. The makers of the diet tablet Meridia were also recently forced to remove it from sale in the US and Canada.

Other drugs have also suffered similar fates. It seems the Food and Drug Administration is getting tougher as to which medications they feel are appropriate for a license.

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