Eli Lilly announced Tuesday that European regulators expanded approval of once-daily Cialis (tadalafil) to include the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Cialis was authorised for erectile dysfunction (ED) in the EU in 2002, with the once-daily version of the therapy approved in the same indication in 2007.
"With this approval, Cialis is now the only medication in the EU to provide a single treatment option for men with both ED and BPH," remarked Anthony Beardsworth, senior medical director at Eli Lilly. He added that "since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a useful therapeutic option for men and physicians."
Cialis was cleared last year by the FDA for the treatment of the signs and symptoms of BPH, as well as for use in men who have both ED and the signs and symptoms of BPH. The therapy is also approved in the BPH indication in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel. Sales of Cialis reached $1.9 billion last year.
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