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EMA recommends Lilly’s erectile dysfunction drug for enlarged prostate

Cialis would be first drug available in Europe for both ED and BPH

Eli Lilly's erectile dysfunction (ED) drug Cialis has been recommended in the EU for the treatment of men with an enlarged prostate.

The European Medicines Agency (EMA) has said the drug should be available to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition that has been shown to occur often in men with ED.

If approved, Cialis (tadalafil) would be the first drug available in Europe to treat both conditions, with Lilly suggesting a potential market of millions of men throughout the region.

The two indications gives 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 is already available in the US to treat both conditions having received approval for BPH in October 2011. This helped towards a slight boost in US sales of Cialis of 3 per cent during the second quarter of 2012, reaching $186.6m.

Other countries where it is also approved for BPH include Canada, Mexico, Brazil, South Korea, Russia, Panama and Argentina.

Lilly also warned that Cialis should not be use by people already taking nitrate medicines, such as isosorbide dinitrate or isosorbide mononitrate.

These drugs are often prescribed for chest pain and can lead to an unsafe drop in blood pressure when combined with a PDE5 inhibitor like Cialis.

A similar warning was given for recreational drugs known as 'poppers', which include amyl and butyl nitrite.

25th September 2012

From: Sales, Regulatory



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