US FDA orders partial hold on GlaxoSmithKline's Avandia TIDE trial

The US Food and Drug Administration yesterday informed UK drug giant GlaxoSmithKline), that the post-marketing trial known as TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) relating to the firm's controversial diabetes drug Avandia (rosiglitazone) has been placed on partial clinical hold.

The move follows the recent FDA advisory meeting, which narrowly voted to retain Avandia on the US market, despite continuing safety worries about the drug's cardiovascular effects (The Pharma Letters July 14 and 15). Under the partial clinical hold no new patients may be enrolled into the trial until further notice from the FDA. Patients already enrolled in the trial will be allowed to continue to participate. The TIDE study is designed to give a definitive assessment of whether Avandia's heart risks are greater than its chief competitor, Japanese drugmaker Takeda's Actos (pioglitazone).

The agency has instructed GSK to update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial regarding new safety information presented at the joint FDA Advisory Committee meeting held on July 13 and 14, along with information regarding the deliberations and votes of that meeting. The FDA says it is evaluating available information on Avandia's safety and the discussions of the recent advisory committee meeting and will update the public on the outcome of its review and its implications for Avandia and the TIDE trial when this is complete.