PharmaTimes | EU needs more time to review Avandia as FDA halts TIDE trial

The European Medicines Agency says it has yet to complete its review on GlaxoSmithKline's controversial diabetes drug Avandia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is investigating the Avandia (rosiglitazone) range of products to determine whether data on the risk of cardiovascular problems have an impact on their benefit-risk profile. The investigation is also covering the drug sold in combination with metformin (Avandamet) and with glimepiride (Avaglim).

The CHMP was expected to report its findings after an EMA monthly meeting this week. Now the agency notes that “preliminary discussions, including with experts in diabetes, cardiovascular diseases and pharmacovigilance and with patients” were held but “additional new data sets have become available very recently”. This, along with the rest of the data, will now be assessed and the review is expected to be finalised by September.

via pharmatimes.com

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