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GSK Regulatory Update On Avandia Following EMA and FDA Reviews

Posted by dlife on Wed, Feb 01, 12, 07:01 AM 0 Comment

September 23, 2010 (GSK) - GlaxoSmithKline (GSK) confirms that following a review of Avandia (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has today announced their individual regulatory decisions and the resulting actions.

In the European Union*, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim). As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA have 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 US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl) will remain available with additional safety labelling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) programme with additional measures to ensure the safe use of the medicine.

Dr. Ellen Strahlman, GSKs 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 in Europe and the US 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. GSK will also work closely with other regulatory agencies to comply with any decisions made by them regarding rosiglitazone-containing medicines. GSK will voluntarily cease promotion of Avandia in all the countries in which it operates and will continue to respond to requests for information and support from healthcare professionals and patients.

Regarding clinical trials, the FDA has imposed a new post-marketing requirement (PMR) for GSK to commission an independent readjudication of the endpoints reported in the large, prospective, randomised, controlled study, RECORD. GSK will provide its full support for this review. The FDA-required TIDE study has been placed on full clinical hold by the agency. TIDE is the only GSK-sponsored clinical trial using Avandia currently being conducted in the US and Europe. GSK in conjunction with the TIDE steering committee will communicate this decision to local regulatory agencies, ethics committees and institutional review boards (IRBS).

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