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FDA Approves Cialis

Lilly ICOS Announces FDA Approval of Cialis (tadalafil), A New Oral Treatment for Erectile Dysfunction

November 21, 2003 -- Lilly ICOS LLC (NYSE: LLY and NASDAQ: ICOS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cialis® (tadalafil), a new oral PDE5 inhibitor, for the treatment of erectile dysfunction (ED). Cialis (pronounced see-AL-iss) was shown to improve erectile function compared to placebo up to 36 hours following dosing. In clinical studies, the ability to have sexual activity was improved in some patients at 30 minutes after taking a dose. Cialis will be available in pharmacies in early December.

"Cialis is an exciting new option for men with ED," said Dr. Francois Eid, clinical associate professor of urology, Weill Cornell Medical College. "Because Cialis works for up to 36 hours, it provides a man and his partner substantial freedom to choose the moment that is right for intimacy. With Cialis, the need for planning intimacy may be reduced."

The safety and efficacy of Cialis was evaluated in 22 clinical trials in more than 4,000 patients. Cialis was shown to be effective in treating ED in patients 27 to 87 years old, including patients with other underlying medical conditions. In two of these trials, men had ED associated with diabetes or following radical prostatectomy for prostate cancer.

"Cialis is a new treatment option for erectile dysfunction that will be available for men in the United States," said Sidney Taurel, chairman and chief executive officer of Eli Lilly and Company. "Erectile dysfunction is a significant medical condition that affects millions of men in the U.S. Men tell us they want an ED treatment that will reduce the constraints of planning and allow them to choose the moment that is right for intimacy."

"Cialis is now available in approximately 50 countries and has been used by more than one million men worldwide, " said Paul Clark, ICOS chairman and chief executive officer. "The early success of Cialis in other markets makes us confident that American men and their partners will appreciate this new treatment option."

Safety Profile

Cialis is not for everyone. Men taking any form of nitrates (often used to control anginal chest pain) should never take Cialis, as the combination may cause an unsafe drop in blood pressure. Men taking medicines called "alpha blockers" (sometimes prescribed for prostate problems or high blood pressure), with the exception of Flomax®1 (tamsulosin HCl) 0.4 mg once-daily, should not take Cialis. This combination could also cause a significant drop in blood pressure.

In clinical trials, the most common side effects with Cialis were headache, upset stomach, backache and muscle ache. Most men weren’t bothered by the side effects enough to stop taking Cialis. In placebo controlled Phase III clinical trials, discontinuation rates in patients treated with Cialis 10 mg or 20 mg was 3.1%, compared to 1.4% in placebo treated patients. Cialis is not recommended in patients who have suffered a heart attack or stroke within the last six months, or patients who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment or retinitis pigmentosa (a rare eye disorder). Men should discuss their health status with their doctors to ensure that Cialis is right for them and that they are healthy enough to engage in sexual activity. Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV.

About ED

ED is defined as the consistent inability to attain and maintain an erection sufficient for satisfactory sexual intercourse.2 It is believed that 85 - 90 percent of ED cases are related to a physical or medical condition, like diabetes or cardiovascular disease, while 10 - 15 percent are due to psychological causes.3 In many cases a combination of both contribute to ED.

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company, was formed to develop and market Cialis.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class 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. Additional information about Lilly is available at www.lilly.com.

ICOS Corporation is a product-driven company that has expertise in both protein-based and small molecule therapeutics. ICOS combines its capabilities in molecular, cellular and structural biology, high throughput drug screening, medicinal chemistry and gene expression profiling to develop highly innovative products expected to have significant commercial potential. ICOS applies its integrated approach to erectile dysfunction and other urologic disorders, sepsis and inflammatory diseases. ICOS' strategy targets multiple therapeutic areas with drugs that act through distinct molecular mechanisms, increasing ICOS' opportunities to market breakthrough products.

to develop highly innovative products expected to have significant commercial potential. ICOS applies its integrated approach to erectile dysfunction and other urologic disorders, sepsis and inflammatory diseases. ICOS' strategy targets multiple therapeutic areas with drugs that act through distinct molecular mechanisms, increasing ICOS' opportunities to market breakthrough products.

For full prescribing information, visit www.cialis.com.

Certain of the matters discussed herein may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the industry, management beliefs and certain assumptions made by management. Investors are cautioned that matters subject to forward-looking statements involve risks and uncertainties, including economic, competitive and other factors discussed in the two companies’ respective filings with the Securities and Exchange Commission, which may affect the business and prospects of the two companies. More specifically, there can be no assurance that this product will achieve commercial success or that competing products will not pre-empt any market opportunity that might exist for the product. The companies undertake no duty to update forward-looking statements.

References

  1. 1. Flomax is a registered trademark of Boehringer Ingelheim
  2. 2. NIH Consensus Development Panel on Impotence. NIH Consensus Conference. Impotence. JAMA. 1993:270:83-90.
  3. 3. Diseases and Conditions: Impotence, <http://www.impotence.org/FAQ/index.asp>. Accessed on Nov. 19, 2003

Source: Lilly ICOS LLC

Posted: November 2003

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