FDA OKs Cialis for Enlarged Prostate

U.S. drug regulators approved Eli Lilly's Cialis drug to treat enlargement of the prostate, expanding use of the blockbuster impotence medicine.

The Food and Drug Administration said Cialis could be labeled for treatment of the signs and symptoms of a non-cancerous enlarged prostate, called benign prostatic hyperplasia (BPH), and also be used for people who have both BPH and erectile dysfunction.

About half of men over 50 suffer from prostate problems, which can cause difficulty urinating.

"BPH can have a big impact on a patient's quality of life," said Scott Monroe, director of the FDA's division of reproductive and urologic products. "Cialis offers these men another treatment option, particularly those who also have ED (erectile dysfunction), which is also common in older men."

U.S. researchers reported in the journal Urology in 2008 that impotence drugs could help reduce the symptoms caused by an enlarged prostate.

The FDA said it has approved eight other drugs to treat BPH, including Merck & Co's Proscar, GlaxoSmithKline's Avodart and Pfizer's Cardura.

In an interview in July, Eli Lilly CEO John Lechleiter said he expects the longer-lasting Cialis to overtake Pfizer's Viagra to become the market leader for impotence drugs.

Cialis, which the FDA approved for impotence in 2003, posted sales of $1.7 billion in 2010, up nine percent from the previous year, while global Viagra sales climbed two percent last year to $1.9 billion.