Obesity Drugs Go Back To The Drawing Board; FDA To Hold Advisory Cmte On CV Risk
This article was originally published in The Pink Sheet Daily
Orexigen halts Contrave development for U.S., but the firm will appeal the division's "unprecedented" trial request through FDA's dispute resolution process.
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Only a superiority trial could give certainty of CV safety for weight-loss medications prior to approval, FDA’s Robert Temple tells the Endocrinologic and Metabolic Drugs Advisory Committee.
Tougher regulatory hurdles introduced three years ago extended the timelines for successful diabetes drug development, discouragiing investment and partnering activity. An ever-increasing incidence of diabetes, metabolic disorders, and obesity continues to drive innovation and the development of new medicines – but with less emphasis on novel mechanisms.
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 New analysis of SCOUT data for Abbott’s withdrawn Meridia (sibutramine) could crop up in the discussion, former panelist says.