Navigation Links
CHMP Recommends Approval of Cialis for the Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia
Date:9/21/2012

INDIANAPOLIS, Sept. 21, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Cialis® (tadalafil) tablets 5 mg for once a day use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The CHMP's opinion is now referred to the European Commission, which has the authority to approve medicines for the European Union (EU). The Commission usually issues a decision within one to two months following the CHMP opinion.

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.

"If approved by the Commission, tadalafil will be the first and only medication approved in the EU to treat men with both erectile dysfunction and benign prostatic hyperplasia," 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 significant therapeutic option for men and physicians."

The CHMP issued its opinion after reviewing safety and efficacy data from 1,500 patients in four clinical studies of BPH, including one study of BPH and ED. Additionally, safety data from the approved indication for erectile dysfunction were included in Lilly's submission. In the BPH and ED study, Cialis 5 mg for once a day use significantly improved scores on the International Prostate Symptom Score (IPSS), a questionnaire evaluating symptoms of BPH, and the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating sexual function.

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 in which the prostate enlarges, which can cause urinary symptoms like needing to go urgently and frequently.

ED is a condition in which the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. Approximately 40 percent of men over 40 have ED.[1]

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.[2],[3],[4]

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 is approved to treat erectile dysfunction (ED) in adult males 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 an ED treatment that is taken every day to help improve erectile function. When taken every day, it may help men be ready for sex anytime between doses or remove the need to plan the timing of sexual activity around taking a pill.

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 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.

[1] 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.
[2] 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.
[3] 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.
[4] 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 )


'/>"/>
SOURCE Eli Lilly and Company
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Use Notebook Studies to Ensure Successful Reusable Device Cleaning Validations, Recommends Microtest Laboratories
2. InnoPharma, Inc., Announces U.S. FDA Approval of Acetylcysteine Solution, USP, 20% for Inhalation or Oral Administration
3. Dehaier Medical Receives SFDA Approval for DHR-CPAP-C5
4. Surefire Medicals Infusion System For Embolization Procedures Receives CE Mark Approval
5. International Isotopes Inc. Announces Nuclear Regulatory Commission Approval Of The Final Environmental Impact Statement For The Planned Depleted Uranium De-Conversion And Fluorine Extraction Processing Facility
6. Eaton Scientific Announces Clinical Trial Plans for Tropine 3 - Company to Seek FDA Approval as Novel Prescription Drug for Non-Hormonal Treatment of Hot Flashes in Menopausal Women
7. UTHealth Receives FDA Approval To Market New Coronary Flow Reserve Quantification Software
8. Perrigo Receives FDA Approval And Commences Launch Of Clobetasol Propionate Shampoo, 0.05%
9. Medical Marijuana Inc. and Canipa Holdings Drive Dixie X and CanChew Gum Toward EU Marketing Approval And Clinical Development
10. Metrics Inc. Announces the Approval and Launch of Generic Oxycodone HCl 5 mg Capsules
11. Qualitest Receives FDA Approval for Levetiracetam Extended-Release Tablets, 500mg and 750mg
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/10/2017)... LAKEWOOD, Colo. , Aug. 10, 2017  Physical Rehabilitation ... Therapy, located in Lakewood, Colorado . The ... Jeff Lipkin , PT, DPT with his staff of ... the University of Pittsburgh and brings over 10 years of ... Belmar PT marks the 10th PRN clinic ...
(Date:8/8/2017)...   Second-quarter 2017 ... loss per share from continuing operations ... 16 percent to $110 million ... to $161 million Second-quarter ... operations increased 8 percent to $0.93 ...
(Date:8/7/2017)... Ind. , Aug. 7, 2017 Zimmer Biomet ... musculoskeletal healthcare, today announced that its Board of Directors has ... for the third quarter of 2017. ... be paid on or about October 27, 2017 to stockholders ... 22, 2017.  Future declarations of dividends are subject to approval ...
Breaking Medicine Technology:
(Date:8/22/2017)... ... 22, 2017 , ... The old adage “you are what ... eating healthy foods. But this well-known piece of nutrition advice ignores that an ... carbohydrates—depends not only on properties of the food but also on properties of ...
(Date:8/22/2017)... ... ... six years, Lightning Labels has sent out a call for users of its custom label ... of their designs. Submissions this year were open from May 18 to July 1 and ... of the sixth annual Photo Contest, along with the prizes they've received:, ...
(Date:8/22/2017)... ... 22, 2017 , ... Five Star Glass is new to the Texas market, but is proudly ... glass for most makes and models, in Grand Prairie, TX, located in the center of ... been a family owned business for the past 40 years with 32 convenient locations in ...
(Date:8/22/2017)... ... August 22, 2017 , ... “Without ... abuse and neglect, and the struggles faced while hoping for a better life. ... published author, Judy Von Bernewitz, who spent 13 years working with deprived/neglected adolescents ...
(Date:8/22/2017)... ... August 22, 2017 , ... John Stewart joins ... Managing Member for t4 Leadership Development & Consulting. He has spent his career ... “success”: physician leadership development, servant leadership, data driven process improvement, and supportive technology. ...
Breaking Medicine News(10 mins):