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Jul 22, 2010

GSK Halts Enrollment for Postmarketing Avandia Trial as FDA Reviews Safety

GSK Halts Enrollment for Postmarketing Avandia Trial as FDA Reviews Safety

European agency also reviewing risks of diabetes drug in light of recent studies. [© vishnukumar - Fotolia.com]

  • GlaxoSmithKline (GSK) confirmed that at FDA’s request it is suspending enrollment of new patients into the Avandia postmarketing trial known as Tide (thiazolidinedione intervention with vitamin D evaluation). The firm says the move will give FDA time to review recommendations by its Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee.

    The joint panel recently voted in favor of letting the Tide study continue if Avandia remains on the market. The trial, which is being carried out under FDA orders, is comparing the cardiovascular safety of Avandia and Actos in patients with type 2 diabetes. Under the new partial hold patients already participating in the study will be allowed to continue.

    The decision to stop new enrolment in Tide comes just a week after the two FDA committees voted in favor of allowing Avandia to remain on the market. Their mid-July meeting resulted in a 20–12 vote in favor of Avandia, albeit with additions to the drug’s current labeling relating to cardiovascular risk factors and/or restrictions.

    “This pause in enrolment will give clinical trial investigators and patients time to learn about the data presented to the FDA advisory committee and the committee’s recommendations,” comments Ellen Strahlman, M.D., GSK’s CMO. “We are committed to working with the FDA in the best interest of diabetic patients.”

    Meanwhile, and in light of recently published meta-analyses apparently confirming that Avandia poses serious cardiovascular risks, the EMEA last week also started a new review into the safety of rosiglitazone-containing medicines. The agency’s Committee for Medicinal Products for Human Use (CHMP) was due to discuss the issue at its plenary meeting of 19–22 July.

    The possibility that Avandia can cause adverse cardiovascular effects was first mooted back in 2007, and that same year an EMEA review concluded that the benefits of thiazolidinedione-containing drugs including Avandia and Actos outweighed their risks. There is no guarantee that the European agency or indeed FDA will come to the same conclusion this year, even with the latter's  advisory committees voting to keep the drug on the market.


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