FDA Clears Belviq With Post Hoc Finding Of Less Than Double Placebo CV Risk

 
• By Cathy Dombrowski

In analyses of both a narrow and a broad search for cardiovascular events in lorcaserin’s clinical trials, the upper bound of the 95% confidence level was less than 2.0, allowing marketing with a full CV outcomes trial to come post-approval, FDA briefing documents reveal.

FDA continues to mull its policy on how much cardiovascular risk to allow for obesity drugs, but agency review documents for Arena Pharmaceuticals Inc.’s Belviq indicate that companies that get their NDAs to the agency before the policy comes out could see a doubling of CV risk as the point beyond which their drugs cannot go.

Sponsors have been working under a cloud of uncertainty about how to incorporate cardiovascular evaluation into their development programs, with...

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