COMUNICADO: European Commission Approves Cialis for the Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia

 

COMUNICADO: European Commission Approves Cialis for the Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia

Actualizado 30/10/2012 14:03:48 CET

-- Cialis becomes the first and only medication approved in the EU for both the signs and symptoms of benign prostatic hyperplasia and erectile dysfunction

INDIANAPOLIS, Oct. 30, 2012 /PRNewswire/ -- Eli Lilly and Company announced today that the European Commission has approved Cialis (tadalafil) tablets 5 mg for once a day use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

The new indication for Cialis 5 mg for once a day use is based on a clinical trial program of four clinical studies of BPH that included 1,500 men, including one study of men with both BPH and erectile dysfunction (ED).

"Cialis is the only medication approved in the EU to treat both BPH symptoms and ED," said Kraig Kinchen, M.D., senior medical director at Lilly. "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 available for doctors."

In addition to the U.S. and EU, Cialis for once a day use has been approved to treat the signs and symptoms of BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel.

The most commonly reported adverse events in patients taking Cialis for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, indigestion, back pain and muscle pain. They were transient and generally mild or moderate.

BPH is a condition where the prostate enlarges, which can cause urinary symptoms. Common symptoms of BPH include:

ED is a condition in which the penis does not fill with enough blood to harden and expand when a man is sexually stimulated, or when he cannot keep an erection. Approximately 40 percent of men over 40 have ED.[i]

BPH and ED are conditions that may occur in the same patient. Several studies have shown that many men with ED also experience the symptoms of BPH.[ii],[iii],[iv]

Tadalafil inhibits an enzyme called phosphodiesterase type 5 (PDE5). By inhibiting PDE5 in the penis, tadalafil helps produce vascular smooth muscle relaxation and increases blood flow. PDE5 enzymes are also found in the smooth muscle of the prostate and bladder. The mechanism for how tadalafil reduces BPH symptoms has not been fully established.

About Tadalafil (Cialis) Tadalafil was approved for the treatment of erectile dysfunction in the EU in 2002. Tadalafil for once a day use was approved for the treatment of erectile dysfunction in the EU in 2007.

Tadalafil is approved to treat erectile dysfunction (ED) in adult males in more than 100 countries throughout the world, including in the United States, Europe, Australia, Mexico and Canada.

There are two different dosing options: tadalafil for once a day use (2.5 and 5 mg) or tadalafil for use as-needed, or 'on-demand'(10 mg and 20 mg). Tadalafil on demand is a prescription only medicine licensed in the EU for the treatment of erectile dysfunction. Tadalafil for once a day use is a prescription ED treatment that is taken every day.Tadalafil on demand may be taken at least 30 minutes prior to sexual activity, with or without food, and may work for up to 36 hours following dosing.

About Eli Lilly and Company Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

This press release contains forward-looking statements about the potential of Cialis for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that Cialis will receive additional regulatory approvals. There is also no guarantee that Cialis will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

[i] Feldman HA et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151(1):54-61.

[ii] Rosen R, Altwein J, Boyle P, Roger SK, Lukacs B, Meuleman E, et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003;44(6):637-649.

[iii] Brookes ST, Link CL, Donovan JL, and McKinlay JB. Relationship between lower urinary tract symptoms and erectile dysfunction: results from the Boston Area community Health Survey. J Urol 2008;179:250-255.

[iv] Gacci M, et al. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol 2011; 60:809-825.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO [http://photos.prnewswire.com/prnh/20031219/LLYLOGO] )

CONTACT: Teresa Shewman, +1-317-433-1888 (office), +1-317-292-8940(mobile), shewmante@lilly.com

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