GlaxoSmithKline drops Avodart for prostate cancer risk reduction

UK pharma giant GlaxoSmithKline (LSE: GSK) says that it will no longer pursue global approval 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.

Dutasteride is approved in over 90 countries (as a monotherapy or in combination with tamsulosin) to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate and, in some countries, reduction in the risk of acute urinary retention (AUR) and BPH-related surgery. Avodart had annual sales of around $1 billion in 2010, but expanded approval was expected to add more than $1 billion to yearly revenue, according to Matrix Corporate Capital analyst Navid Malik (The Pharma Letter January 28).

In January, GSK received a Complete Response letter following a US Food and Drug Administration Oncologic Drugs Advisory Committee Meeting (ODAC) in December 2010, when the majority voted against a favorable risk/benefit profile for dutasteride for reduction in the risk of prostate cancer in men at risk for the disease. A similar communication was received by Merck & Co for its Proscar (finasteride).