CV Trials For Obesity Drugs Won’t Be Conducive To Easy Interpretation, Panel Indicates
This article was originally published in The Pink Sheet Daily
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will discuss design issues March 29 and vote on the need for pre-approval trials in drugs without a CV safety signal.
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The Endocrinologic and Metabolic Drugs Advisory Committee also will evaluate methods for collecting cardiovascular risk information for obesity drugs with a CV safety signal, as FDA seeks input on when and how sponsors should evaluate their products.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.