Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers

BY CHELSEY MCINTYRE, PHARMD

Although the prevalence of overweight and obesity in Europe exceeds 50%, the EMA does not currently offer guidance to sponsors on investigating the effects of obesity during drug development. Last week, the agency finalized a reflection paper that has been available only in draft form for the past six years. The paper reaffirms the importance of obesity to drug disposition but offers little in the way of recommendations and guidance to sponsors.

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