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GSK gives up on Avodart for cancer risk

GlaxoSmithKline has given up on efforts to secure marketing approval for the use of its benign prostatic hyperplasia drug Avodart for the new indication of reducing the risk of prostate cancer

GlaxoSmithKline (GSK) has decided to give up on global efforts to secure marketing approval for the use of its marketed benign prostatic hyperplasia (BPH) drug Avodart (dutasteride) for the new indication of reducing the risk of prostate cancer.

"Overall, a combination of factors including the ongoing medical and scientific debate around the benefits and risks of 5ARIs (dual 5-alpha reductase inhibitors) 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," according to the company.

GSK said it believes that dutasteride for BPH continues to have a favourable risk/benefit profile.

The company plans to withdraw its applications for prostate cancer risk reduction from regulatory review where procedures are ongoing. In addition, in the few countries where the drug has been approved for the new use, GSK will work with regulatory authorities to have the indication removed.

The US Food and Drug Administration (FDA) recently issued a complete response letter declining to approve the new indication. GSK had been seeking permission from the FDA and other global regulatory bodies to market the drug to reduce prostate cancer risk in men who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen.

In December, the FDA's Oncologic Drugs Advisory Committee voted 14 to 2 to recommend against approval of the new indication. The advisors pointed out that although a four-year study showed that at-risk men taking the drug were 23 per cent less likely to develop prostate cancer, more men on the drug than on placebo developed aggressive tumours.

Avodart was launched for BPH in the US in 2003 and had global sales of about $830m last year. Some financial analysts had originally predicted that a prostate cancer risk reduction indication could more than double those sales.

24th March 2011

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