(Mealey's) The European Medicines Agency (EMA) on Sept. 23 recommended that the marketing authorization for GlaxoSmithKline PLC's (GSK) controversial anti-diabetes drug Avandia be suspended, and the Food and Drug Administration simultaneously said it will significantly restrict Avandia use in response to data that suggest that the drug carries an elevated risk of cardiovascular events, such as heart attack and stroke.
The FDA said it will require GSK to develop a restricted-access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class.
The FDA said current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.
Under the new restrictions, the FDA said doctors will have to attest to and document their patients' eligibility to take Avandia. Patients will also have to review statements describing the cardiovascular safety concerns associated with the drug and acknowledge that they understand the risks.
Also on Sept. 23, the FDA ordered GSK to convene an independent group of scientists to review key aspects of the company's Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia (RECORD) clinical trial, which was ordered by European regulators several years ago to study the cardiovascular safety of Avandia compared to standard diabetes drugs. The FDA said that during its review of the RECORD study, "important questions arose about potential bias in the identification of cardiovascular events."
The agency said it is requiring the independent review "to provide additional clarity about the findings." The FDA said it may take additional actions after GSK's independent reanalysis of RECORD is completed.
In addition, the agency ordered a halt to the controversial Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) study that it ordered GSK to conduct in 2007 after concerns first emerged about significant heart risks from Avandia.
The EMA said its Committee for Medicinal Products for Human Use "could not identify additional measures that would reduce the cardiovascular risk" from Avandia. "The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines," the agency said.
EMA said the suspension will remain in place unless GSK "can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks."
[Editor's Note: Full coverage will be in the Oct. 7 issue of Mealey's Emerging Drugs & Devices. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
For more information, call editor Tom Moylan at 610-205-1120, or e-mail him at firstname.lastname@example.org.