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Advisory Committee Set To Review Cardiovascular Risk Assessment For Obesity Drugs

 
• By Emily Hayes

Recent guidance on Orexigen’s Contrave could provide clues about how the agency is leaning on drugs in the highly safety conscious obesity category. New analysis of SCOUT data for Abbott’s withdrawn Meridia (sibutramine) could crop up in the discussion, former panelist says.

The uncertainty that has plagued obesity drugs submitted for approval in a difficult-to-predict regulatory environment could soon be cleared up. FDA’s Endocrinologic and Metabolics Drugs Advisory Committee is set to meet March 28-29 to discuss cardiovascular assessment of obesity drugs before and after approval.

Though guidance has been in place for obesity drugs, there has been considerable uncertainty about the appropriate regulatory standards for weight-loss drugs. This has meant negative consequences for three weight loss drugs filed in recent years, as evidenced by advisory committee discussions on Orexigen Therapeutics Inc./Takeda Pharmaceutical Co. Ltd. ’s Contrave (naltrexone/bupropion); Arena Pharmaceuticals Inc

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