Regulators in Europe have given the green light to Eli Lilly's erectile dysfunction drug Cialis as a treatment for enlarged prostate.

The European Commission has approved Cialis (tadalafil) for once-daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The drug was approved for ED in the EU in 2002, and the latest thumbs-up comes just over a year after the US Food and Drug Administration cleared Cialis for BPH.

Anthony Beardsworth, senior medical director at Lilly, said that 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". He noted that since many men with ED suffer from the latter, a single drug to treat both "may be a useful therapeutic option".

Lilly added that Cialis should not be used in patients taking nitrates, because the combination can cause an unsafe decrease in blood pressure. In addition to the USA and the EU, Cialis is approved for BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel.

The latest green light will boost Cialis sales which are already pretty healthy. Third-quarter turnover of the drug came in at $482.1 million (+3%). The BPH market is a competitive one and Cialis will go up against the likes of Merck & Co's Proscar (finasteride) and GlaxoSmithKline's Avodart (dutasteride) and Jalyn (dutasteride plus tamsulosin), plus alpha blockers like Boehringer Ingelheim's Flomax (tamsulosin) and Sanofi's Uroxatral (alfuzosin).