GSK EU regulatory update on Avandia (rosiglitazone)
GlaxoSmithKline (GSK) confirmed that on behalf of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) is to review the benefit/risk profile of Avandia (rosiglitazone). This follows the recent publication of an observational study and a meta-analysis regarding Avandia since the CHMP last reviewed the product in early 2010. All data generated by the Company has previously been submitted to the EMA.
The Committee is expected to review and discuss the data with the company during its scheduled meeting on 19-22 July.
FDA Advisory Committees are also scheduled to convene 13-14 July to review all the latest available data on Avandia.
Dr Tony Hoos, European Medical Director for GlaxoSmithKline said: "GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients. It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients. Diabetes is a chronic, long term condition with serious consequences, and patients should not stop taking rosiglitazone, or any other medicine for type 2 diabetes, without consulting their doctor."
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