The wait for the release of a new weight-loss drug got longer recently as regulatory decisions were not in favor of fat-fighting treatments. The US Food and Drug Administration decided in October not to approve two anti-obesity treatments, sending complete response letters (CRLs) to the drugs’ sponsors.
In both cases, FDA followed the advice of the Endocrinologic and Metabolic Drugs Advisory Committee, which recommended that the two drugs, Qnexa (phentermine/topiramate) by Vivus (Mountain View, CA) and lorcaserin hydrochloride by Arena Pharmaceuticals (San Diego), not be approved because of health risks. In the CRL for Qnexa, FDA requested more study results and information about the drug’s risks such as cardiovascular events and birth defects, according to Vivus. Arena announced that FDA’s main concerns with lorcaserin were that early testing showed mammary tumors in rats, and that the weight-loss experienced by people without Type 2 diabetes in clinical trials was marginal. FDA asked for more data and said more clinical testing may be required if concerns about the tumors are not alleviated.
Another setback for obesity treatments was the voluntary recall of Meridia (sibutramine) in the US and Canada by Abbott (Abbott Park, IL) in October. FDA requested the recall due to risks of stroke and cardiovascular side effects. Meridia was banned in Europe in January.
There is hope, however, for approval of a third new treatment. Contrave (naltrexone sustained release [SR]/bupropion SR), by Orexigen Therapeutics (San Diego), will face the advisory committee early next month, on Dec. 7. FDA will decide by Jan. 31, 2011 whether to approve the drug.
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