GSK no longer will seek approval for Avodart
LONDON — GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.
The drug maker announced it no longer would pursue global approval for Avodart (dutasteride) and would work with regulatory agencies to remove the indication from the product’s license.
In late 2009, GSK began filing applications with regulatory agencies worldwide for the use of dutasteride to reduce the risk of prostate cancer. The drug maker received a complete response letter from the Food and Drug Administration's Oncologic Drugs advisory committee this past January, which ruled against Avodart's favorable risk/benefit profile for reduction in the risk of prostate cancer in men at risk for the disease.