GlaxoSmithKline (NYSE:GSK) drug Avodart, already approved for treating enlargement of the prostate gland, has been rejected by the Food and Drug Administration for the additional indication of reducing the risk of prostate cancer.
GSK said that the company has received a complete response letter from the FDA regarding its supplemental new drug application for Avodart. Such letters mean the agency needs more information from the pharmaceutical company before it can grant approval. Complete response letters typically outline what a company must do in order to gain approval. London-based GSK, which has its U.S. headquarters in North Carolina’s Research Triangle Park, did not say what concerns the FDA has or what the company must do to receive approval for the additional use of Avodart.
Avodart received FDA approval in 2002 to treat patients with symptomatic benign prostatic hyperplasia, or BPH, known more simply as an enlarged prostate.The drug works by blocking enzymes that promote prostate growth. Avodart shrinks the prostate, relieving symptoms such as frequent and difficult urination. Use of the drug also decreases the need for BPH-related surgery.
Avodart is already a major drug for GSK, representing $246 million in sales in the third quarter of 2010. Results of a clinical study in 2009 showed that Avodart also reduced the risk of prostate cancer. An additional indication for prostate cancer could further boost sales of Avodart, as well as extend the life of the drug beyond its 2015 patent expiration. GSK said that the FDA’s response to the company’s application refers only to the cancer risk reduction and not to the already approved uses of the drug.
