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.
In the meantime, the EMA has told doctors to “strictly follow the recommendations in the product information” on the Avandia label. Separately, the agency has also confirmed that GSK’s oral vaccine Rotarix “continues to have a positive benefit-risk balance” following a review and that the presence of a very small amount of viral particles reported by the company does not present a risk to public health.
The European review of Avandia follows in the wake of a high-profile US Food and Drug Administration advisory committee meeting last week which voted to recommend that the therapy be allowed to remain on the market but with additional warnings. The vote was a major boost for GSK which has suffered a barrage of criticism over the drug.
However, things never seem to be that simple where Avandia is involved and the FDA has informed GSK that its postmarketing trial known as TIDE, assessing the cardiovascular risks of the drug compared to Takeda’s Actos (pioglitazone), has been placed on partial clinical hold.
The agency has instructed GSK to update investigators, institutional review boards and ethics committees involved in the TIDE trial regarding new safety information presented at the aforementioned advisory committee review, “along with information regarding the deliberations and votes of that meeting”.
