Majority vote from FDA advisory panel to ease restrictions on GSK's Avandia

A joint advisory committee to the US Food and Drug Administration (FDA) voted to continue to make UK pharma giant GlaxoSmithKline’s (LSE: GSK) diabetes drug Avandia (rosiglitazone) available to appropriate patients with the majority of the 26 panel members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program in place. Remaining members voted to continue the REMS (5) or withdraw (1) Avandia from the US market.

The committee discussion overall reflected confidence in the integrity and reliability of RECORD. The independent re-examination of the RECORD study was conducted by the Duke Clinical Research Institute (DCRI) for GSK and confirmed the study’s original findings: that the risks of mortality and major adverse cardiac events with Avandia in combination with metformin or SU are no different than with a combination of metformin and SU [without Avandia].

Avandia, which lost patent protection in 2011, had peak sales of some $3 billion, but these had dwindled to just $9.5 million by 2012 due restrictions on use of the type 2 diabetes treatment because of concerns about the risk of death, heart attack or stroke, and total withdrawal from the European market (The Pharma Letter September 24, 2010).