The FDA makes its decision on Avandia

FDA logo for illustration purposes only.

On September 23, 2010, the FDA made its decision on  what to do about the antidiabetic drug rosiglitazone (GlaxoSmithKline’s [GSK’s] Avandia), based largely on the July 15, 2010 recommendations of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee. That committee had voted to keep Avandia on the market with some new restrictions, because of cardiovascular safety concerns with the drug. But the committee was deeply divided with respect to the specifics of these restrictions, and whether Avandia should remain on the market at all.

The FDA decided to restrict access to Avandia by requiring GSK to submit a Risk Evaluation and Mitigation Strategy (REMS). After implementation of the REMS, Avandia will be available to patients not already taking it only if they are unable to achieve glycemic control using other drugs and, who decide not to take pioglitazone (Takeda’s Actos) for medical reasons in consultation with their physician. Patients now on Avandia will be able to continue using the drug if they appear to be benefiting from it and they acknowledge that they understand the drug’s risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns. These new restrictions should significantly limit the use of Avandia, whose use has already declined precipitously.

FDA officials Drs. Janet Woodcock, Joshua Sharfstein, and Margaret Hamburg (who is the FDA Commissioner) published the reasoning behind their decision in the New England Journal of Medicine.

On September 23, 2010, the European Medicines Agency (EMA) also took regulatory action on rosiglitazone. This agency recommended that the drug, marketed as Avandia, Avandamet and Avaglim in Europe, be taken off the market. These drugs will no longer be available in Europe within the next few months. The EMA published a question and answer document on its action.

During August and September 2010, we published a series of three articles on this blog on the safety issues with rosiglitazone and the other marketed drug of the insulin sensitizing thiazolidinedione (TZD) class pioglitazone, as well as how the biotechnology/pharmaceutical industry might develop improved, safer, and more efficacious insulin sensitizers. These articles are:

Please read these articles if you have not already done so.

Because of the key importance of insulin resistance in the pathogenesis of type 2 diabetes, and because of the major unmet needs in treatment of this disease, we believe that it is important to work to develop novel, innovative insulin sensitizers that can overcome the deficiencies of the TZDs and hopefully fill at least some of these unmet needs. These articles outline ways in which the industry might be able to accomplish this objective.

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