GSK announces regulatory update from EMA and US FDA on diabetes drug

GlaxoSmithKline (GSK) confirms that following a review of its Type 2 diabetes treatment Avandia® (rosiglitazone maleate) by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), each agency has announced their individual regulatory decisions and the resulting actions.

In the US, all rosiglitazone-containing medicines will remain available with additional safety labelling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) program with additional measures to ensure the safe use of the medicine.

In the European Union, the EMA has suspended the marketing authorization for all rosiglitazone-containing medicines. As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA has stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.

In the Philippines, the rosiglitazone range continues to be available in the market. GSK is working with the local Food and Drugs Administration to provide the latest regulatory updates and is ready to comply with its decision on rosiglitazone-containing medicines in the country. Patients are advised to discuss their treatment with their doctors and not to just stop taking rosiglitazone without having appropriate treatment for their type 2 diabetes.

Dr. Ellen Strahlman, GSK’s Chief Medical Officer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians have all the information they need to help them understand how these regulatory decisions affect them and their patients.”

The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions.