FDA panel in favour of easing GSK’s Avandia restrictions

The results of the recent FDA advisory panel’s meeting regarding GlaxoSmithKline’s diabetes drug Avandia are in.

The majority of a 26-member non-medical panel voted to recommend the easing of safety restrictions that were placed on Avandia (rosiglitazone) in 2010. The panel was narrowly divided – 13 members favoured modification, seven voted to remove the restrictions altogether, five panel members favoured keeping current safeguards in place without changes and one voted to remove the drug from the market.

The Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee’s decision could have laid the groundwork for further research into Avandia’s health risks. The US FDA will take this recommendation into consideration for a final decision on how the drug can be used.

“We appreciate the committee’s thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendation of the committee. We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labelling.”
Dr. James Shannon, GSK’s Chief Medical Officer.

Pending the FDA’s decision, Avandia will be available through the Risk Evaluation and Mitigation Strategy (REMS) program to physicians and appropriate patients as an option to help control blood sugar in patients with type 2 diabetes.



Related news:

FDA panel narrowly votes to modify Avandia restrictions (Reuters)

Reference links:

GSK statement

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