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The Company will withdraw applications from regulatory review where procedures are ongoing and, in the limited number of countries where dutasteride is already indicated for use in prostate cancer risk reduction, GSK will work with regulatory agencies to remove this indication from the product’s licence and support physicians to communicate appropriately to patients. The prostate cancer risk reduction applications were based on findings from the Phase III REDUCE trial (REduction by DUtasteride of prostate Cancer Events) which were first presented at the American Urological Association Annual Meeting, April 2009 and subsequently published in the New England Journal of Medicine in 2010. As a result of GSK’s continuing evaluation of available data, GSK began filing applications with regulatory agencies worldwide for the use of dutasteride to reduce the risk of prostate cancer from the end of 2009. In January 2011, GSK received a Complete Response letter following a US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee Meeting (ODAC) in December 2010, when the majority voted against a favourable risk/benefit profile for dutasteride for reduction in the risk of prostate cancer in men at risk for the disease. This was essentially due toquestions regarding the clinical significance of reducing the risk of low grade prostate cancer, and uncertainties surrounding the possible explanations for the increased number of cases of high grade tumours in men treated with 5-alpha reductase inhibitors (5ARIs) for prostate cancer risk reduction. Following similar feedback from Sweden, the Reference Member State in Europe, received in February 2011, GSK has now notified the Swedish MPA of its withdrawal from the regulatory review. 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