Important deadline for FDA coming up

March 3rd, 2012 by MorganDowney Leave a reply »
 

March 14 is coming up and it is an important date. It is the deadline for written comments to the Food and Drug Administration for the March meeting of the Endocrinologic and Metabolic Drug Advisory Committees. The meeting is not to review any specific drug but rather the “role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.”  (For full information on filing written comments see,    Advisory Committee Calendar > March 28-29, 2012: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement   )

A member of the EDMAC made the comment at the last meeting that all obesity drugs were basically diabetes drugs and the same rules that apply to diabetes drugs, in terms of cardiovascular risk, should apply to obesity drugs. When Qnexa was approved, its high level of effectiveness tipped the scales in favor of a post-approval cardiovascular study, a la SCOUT. However, the FDA has not made a final decision. This meeting might prove decisive in whether long-term cardiovascular trials will be required pre-approval for obesity drugs.

One of the interesting aspects of this discussion will be the contrast between cardiovascular study design, which calls for an older, sicker population in order to have a sufficient number of events versus the clinical population usually seen in obesity practices. This was a major issue in the interpretation of the SCOUT trial and the EDMAC hearing on Meridia.

Sure to come up at the next Ad Com will be an evaluation of the cardiovascular risks in SCOUT which found that modest weight loss of approximately 3 kg appeared to offset the increased cardiovascular mortality of sibutramine for the following 5 years, even in those with pre-existing cardiovascular disease. Maintained intentional weight loss reduc… [Diabetes Obes Metab. 2011] – PubMed – NCBI

The guidances for approval of drugs for the treatment of type 2 diabetes is found at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071627.pdf

For background on the FDA review of obesity drugs, see my article, Is there a path for appro… [Curr Opin Endocrinol Diabetes Obes. 2011] – PubMed – NCBI