LONDON, Sept. 23 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE and LSE: 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 authorization 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 labeling 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.
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 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 reajudication of the endpoints reported in the large, prospective, randomized, 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).
Total Avandia sales in the first half of 2010 were 321m pounds Sterling (-18%); US 164m pounds Sterling (-23%); Europe72m pounds Sterling (-17%); Emerging Markets 37m pounds Sterling (-5%); RoW 48m pounds Sterling (-6%)**. As a result of the regulatory updates in both the US and EU, GSK now expects global sales of Avandia products to be in a range of approximately 100m pounds Sterling - 150m pounds Sterling in the second half of 2010 and with minimal annual sales thereafter. These estimates are net of customer returns of product previously sold. Associated one-off costs in 2010 comprising stock write-offs, asset write-offs and other related one-off costs are currently expected to be approximately 100m pounds Sterling on a pre-tax basis.
To access the full EMA announcement visit www.ema.europa.eu.
To access the full FDA announcement visit www.fda.gov.
GlaxoSmithKline 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.
* The 27 voting members of the EMA are Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. In addition, Norway, Iceland and Liechtenstein who are non-voting members of the EMA are also affected.
** All growth rates are shown at constant exchange rates and relate to the prior comparative period
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.