After rejecting two obesity-drug candidates in recent months, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended two weeks ago that the agency approve a third drug, Contrave (naltrexone sustained release [SR]/bupropion SR) by Orexigen Therapeutics (San Diego). Members of the expert panel voted 13–7 to approve the drug, but recommended that additional studies be conducted to investigate potential heart risks.
If FDA approves Contrave, it will become the first new prescription weight-loss treatment in more than a decade. The agency, which isn’t required to follow the advice of its expert panels but usually does, is set to decide on the drug’s status by Jan. 31, 2011.
This week, FDA personnel met with executives from Arena Pharmaceuticals (San Francisco), developer of the rejected obesity drug lorcaserin, and outlined a plan for the company to resubmit its new drug application and seek future approval. Arena President and CEO Jack Lief said in a company statement that the company expects to refile the NDA by the end of 2011.
In September, lorcaserin was rejected, in a 9–5 vote, by the panel because of concerns that early testing showed mammary tumors in rats. In October, Arena said in a press statement that FDA’s complete response letter (CRL) stated concerns about the tumor risks, as well as the drug’s efficacy, stating that the weight-loss experienced by people without Type 2 diabetes in clinical trials was marginal.
Qnexa (phentermine/topiramate) by Vivus (Mountain View, CA) was also rejected (in a vote of 10–6) by FDA’s committee in July because of health risks, specifically, concerns about cardiovascular problems and birth defects. Vivus said last week that it submitted a briefing document to FDA to address the agency’s concerns in its CRL, and will meet with FDA’s endocrine and metabolic division in January to discuss resubmission possibilities.
On Monday, Vivus began the approval process for Qnexa in Europe by filing a marketing authorization application with the European Medicines Agency. The company said the drug could receive approval late next year.
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