Lilly's Cialis cleared for BPH in Europe

Eli Lilly's erectile dysfunction drug Cialis has been cleared for the treatment of benign prostatic hyperplasia (BPH) in Europe, opening up a lucrative new market for the drug.

The European Commission approved Cialis (tadalafil) as a once-daily treatment for the signs and symptoms of BPH five years after approving it for ED, and a year after Cialis got a green light for BPH in the US.

"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," commented Anthony Beardsworth, senior medical director at Lilly.

Approximately 50 per cent of men between 40-70 years old have experienced ED, while a similar proportion of the over-50s develop symptoms linked to enlargement of the prostate.

"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."

The two indications give Cialis a potential advantage over drugs approved for just one or the other, including Pfizer's Viagra (sildenafil) for ED and Abbott's Hytrin (terazosin HCl) for BPH.

Cialis has been a big earner for Lilly as an ED treatment since first debuting on the market in 2002, and is currently the company's fourth-biggest product, bringing in sales of $1.38bn in the first nine months of 2012.

While Cialis sales in ED have been flattening of late, particularly outside the US, approval in BPH seems to have injected a little momentum into the product with sales up 2 per cent in the first nine months of the year and 3 per cent in the third quarter.

In addition to the US and EU, Cialis has been given the green light for BPH treatment in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel.