Lilly's ED treatment Cialis wins prostate indication

Eli Lilly ($LLY) just won FDA approval for an enlarged-prostate treatment. That's a bit of good news that only goes so far, as the market for benign prostatic hyperplasia treatments is rather full. The FDA counts 8 other drugs indicated to treat BPH, including Merck's ($MRK) Proscar, Pfizer's ($PFE) Cardura, Boehringer Ingelheim's Flomax, and GlaxoSmithKline's ($GSK) Avodart and Jalyn.

But the drug Lilly can now market as a BPH med is Cialis, the erectile dysfunction treatment. Men with enlarged prostates can get relief from those symptoms while enjoying a boost to their sex lives. Men who are self-conscious or embarrassed about seeking treatment for ED might be less hesitant to ask for a BPH therapy.

"BPH can have a big impact on a patient's quality of life," Scott Monroe, FDA's director of reproductive and urologic drugs, said in a statement. "A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men."

The new approval actually covers two indications: One for men with both ED and BPH symptoms, and one for men with BPH signs and symptoms only. FDA granted the new uses based on three studies, one in men with both conditions, and two in men with BPH.

- see the FDA statement
- get more from RTT News
- read the Reuters news

Suggested Articles

Look out, diabetes market: Novo Nordisk won its FDA nod for highly anticipated Rybelsus to control blood sugar in patients with Type 2 diabetes.

Insys is in fire sale mode as part of its bankruptcy plan, and now it’s been given the go-ahead to sell the opioid that helped get it there.

GSK CEO Emma Walmsley could soon have a new title: Microsoft board member. The software giant has nominated her to its board of directors.