GSK statement on Avodart™ (dutasteride) for prostate cancer risk reduction

GlaxoSmithKline (GSK) announced today that it will no longer pursue global approval (marketing authorisation) for the use of Avodart™ (dutasteride) to reduce the risk of prostate cancer. 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 2010.1

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.

Regulatory filings were also made in other countries outside the US and EU resulting in a small number of countries approving the indication.

Overall, a combination of factors including the ongoing medical and scientific debate around the benefits and risks of 5ARIs for prostate cancer risk reduction, together with feedback from regulatory agencies has caused GSK to carefully consider its approach to the indication and subsequently withdraw ongoing applications for approval.

Dutasteride use in benign prostatic hyperplasia (BPH)

Dutasteride is approved in over 90 countries (as a monotherapy or in combination with tamsulosin) to treat the symptoms of BPH in men with an enlarged prostate and, in some countries, reduction in the risk of acute urinary retention (AUR) and BPH-related surgery.

GSK reviews the safety and performance of all its medicines on a continuous basis and is committed to further investigations to advance the understanding of the benefits and risks of dutasteride. To that end, dutasteride has been extensively studied in clinical trials involving 7,500 men with BPH and has an estimated 6.6 million patient-years of exposure. As a result of these evaluations, GSK believes that dutasteride for BPH continues to have a favourable risk/benefit profile.

As part of its continuing dialogue with regulatory agencies GSK is working with them to update the existing labels for all dutasteride-containing medicines†. The update for physicians and patients will include relevant safety information from the REDUCE study and will continue to emphasise the importance of regular PSA monitoring. GSK will also provide communications to physicians to facilitate awareness and understanding of any changes.