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Founded by Eli Lilly in 1876, it is now the 10th largest pharmaceutical company in the world.
Eli Lilly's Cialis gets FDA approval for two more indications
Eli Lilly and Company (NYSE:LLY) announced Friday that its Cialis drug, first intended for the treatment of erectile dysfunction (ED), has now received US FDA approval for another two indications: for the treatment of benign prostatic hyperplasia (BPH), and BPH and ED together.
The new indications cover the drug's once-daily formula, and are based on three clinical trials that evaluated nearly 2,000 men. Two of the placebo-controlled trials examined the efficacy and safety of the drug in men with BPH, while the third study evaluated the safety and efficacy of the drug in men with both ED and BPH.
BPH is a condition characterized by an enlarged prostate, which can partially or completely obstruct the urethra, causing several urinary symptoms, including difficult, painful, and frequent urination, and a higher risk of urinary tract infections.
ED, affecting approximately 50% of men between the ages of 40 and 70 years old, is a condition where the penis does not fill with enough blood to harden and expand during sexual arousal.
Eli Lilly said studies have found that these conditions can co-exist in a single patient.
Cialis, which uses tadalafil, treats ED by inhibiting the phosphodiesterase type 5 (PDE5) enzyme in the penis, relaxing the blood vessels and improving blood flow. Eli Lilly said this particular enzyme is also present in the prostate and bladder, allowing for Cialis to also treat the symptoms of BPH, though it could not define a specific mechanism pathway.
Eli Lilly's President Dave Ricks said: "These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health.
"We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH."
Eli Lilly shares rose in premarket trading today, before rising another 0.75% as of 9:14 am EDT, to trade at $37.51.


















