GlaxoSmithKline (NYSE: GSK) will no longer pursue global regulatory approval to market its Avodart drug to treat prostate cancer following negative feedback from American and Swedish regulators.
Avodart is approved in more than 90 countries to treat an enlarged prostate.
“The Company will withdraw applications from regulatory review where procedures are ongoing and, in the limited number of countries where [Avodart] 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 license and support physicians to communicate appropriately to patients,” GSK said.
In January, a U.S. federal health panel voted against GSK’s move to expand the drug’s application. The panel found that Avodart’s use could actually raise the risk of the most serious types of tumors.
“This was essentially due to questions 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 tumors in men treated with 5-alpha reductase inhibitors (5ARIs) for prostate cancer risk reduction,” GSK said.
GSK said Wednesday it had received similar feedback from Swedish health authorities and withdrawn its filing there for a regulatory review.
The company said it will work to ensure product licenses in countries currently allowing Avodart’s use in cancer reduction reflect the change.
GSK operates its U.S. headquarters in RTP.
Read GSK’s full statement here.
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