FDA approves Lilly's Cialis to treat benign prostatic hyperplasia

The US Food and Drug Administration yesterday approved drug major Eli Lilly’s (NYSE: LLY) Cialis (tadalafil), currently marketed for the treatment of erectile dysfunction, to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and ED, when the conditions occur simultaneously.

Cialis was approved in 2003 for the treatment of ED, and last year generated sales of $1.7 billion, just slightly less than the sector leader, Pfizer’s Viagra (sildenafil) at $1.9 billion, but Cialis sales are growing faster than the latter, rising 9% to $477.2 million in the second quarter of this year, compared with a 2% increase for Viagra.

The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who took 5mg of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.