FDA approves Avandia (rosiglitazone) label update, lifts restrictions on patient access

Issued: 7 May 2014, London UK

GSK plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved changes to the labeling and restricted access program for Avandia, Avandamet and Avandaryl for type 2 diabetes. These rosiglitazone-containing medicines, available through specialty pharmacy only since 2011, will once again be available for patients through retail pharmacies.

The FDA notified GSK in November 2013 that it would require changes to the label and the restricted access program (the Risk Evaluation and Mitigation Strategy or REMS Program). The decision for a REMS modification followed a June 2013 FDA Advisory Committee review of the re-adjudication of a large clinical trial with Avandia that looked at cardiovascular outcomes - the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial. The FDA concluded that results from the RECORD trial showed the risk of major adverse cardiovascular events, which include heart attack, or death in patients being treated with Avandia is not different compared to standard-of-care diabetes drugs.

FDA required restrictions be placed on patient access to Avandia, Avandamet and Avandaryl in the 2010 REMS Program requirement when questions were raised about the cardiovascular safety of Avandia based on a meta-analysis of clinical trials. The FDA had required physicians to be specially trained and registered to prescribe the medicines, required pharmacies to be registered to dispense the medicines and that access be limited to patients already taking the medicines and benefitting from it or new patients who were unable to be controlled on other diabetes medicines.

In the current REMS modification, any physician may now prescribe rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl) to be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus. A revised REMS website (www.rosiglitazonerems.com) will provide training about the current state of knowledge of the cardiovascular safety of rosiglitazone-containing medicines as well as links to the Prescribing Information and Medication Guides and a Dear Healthcare Professional Letter which further informs about the changes in access to rosiglitazone-containing medicines.

Rosiglitazone-containing medicines will continue to be available through the pharmacies that previously participated in the REMS program.  In addition, other pharmacies now may order rosiglitazone-containing medicines directly from their GSK authorized wholesaler.

To assist in the transition, a toll-free telephone number has been established for patients, healthcare professionals and pharmacies to ask questions. They can call the Rosiglitazone REMS Program Coordinating Center at 1-800-282-6342, Monday through Friday from 8:30 AM to 5:00 PM ET.

GSK - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

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