FDA Approves New Indication for Yaz to Treat Acne
WAYNE, N.J., January 29, 2007 /PRNewswire/ -- Berlex, Inc., a U.S. affiliate of Bayer Schering Pharma, Germany, announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for YAZ(R) (3 mg drospirenone/20 mcg ethinyl estradiol) to treat moderate acne vulgaris in women who desire an oral contraceptive for birth control. Acne is one of the most common skin disorders in the United States.
With today's decision, YAZ becomes the first and only oral contraceptive ever approved by the FDA for three distinct indications. YAZ received FDA approval as an oral contraceptive in March 2006, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who desire an oral contraceptive in October 2006. YAZ is the only oral contraceptive that has demonstrated statistical and clinical significance in treating premenstrual irritability, moodiness, feeling anxious, bloating and increased appetite that are severe enough to impact a woman's activities, work or relationships.
"This latest regulatory approval underscores the culmination of years of research that confirms the promise of YAZ and the distinctness of our innovative progestin, drospirenone, in delivering benefits that are beyond reliable birth control," said Reinhard Franzen, President and CEO of Berlex Laboratories.
Unlike other progestins, drospirenone has unique antimineralocorticoid (mild diuretic effect) and antiandrogenic properties. "The antiandrogenic property of drospirenone means that it blocks the male sex hormones that can cause acne," said Ian Thorneycroft, Ph.D., M.D., professor of obstetrics and gynecology at the University of South Alabama.
"Therefore, it is not surprising that this combination of hormones in a longer active pill regimen treats severe menstrual issues that women experience as well as acne," he added. Studies show that acne tends to flare up in women just prior to or during menstruation.
Data Demonstrate Safety, Efficacy and Tolerability of YAZ for Acne
Two six-month multicenter, double-blind, placebo-controlled, randomized clinical trials of over 1000 patients revealed the statistically significant efficacy of YAZ in treating moderate acne. In the trials, treatment with YAZ resulted in significant reductions in total, inflammatory and non inflammatory acne lesion counts. Further, investigator ratings of "clear" and "almost clear" skin as rated on the Investigator's Static Global Assessment (ISGA) scale were nearly four times greater in the YAZ treatment group than the ratings of patients in the placebo group.
YAZ was well tolerated by the majority of women in these clinical studies. The most common side effects in the acne clinical trials include upper respiratory infection, irregular bleeding, headache, nausea, sinusitis, and yeast infection.
Important Information about YAZ
YAZ contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone. YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.
OCs do not protect against HIV infection and other sexually transmitted diseases. The use of OCs is associated with increased risks of several serious side effects including venous and arterial thrombotic and thromboembolic events. Cigarette smoking increases the risk of serious cardiovascular side effects; women, particularly those 35 and older, who take OCs are strongly advised not to smoke.
Information for Consumers
Women who would like to learn more about YAZ should call the toll-free number 1-888-BERLEX-4 or visit www.yaz-us.com.
Berlex, Inc. is a U.S. affiliate of Bayer Schering Pharma, Germany, which is a subsidiary of Bayer AG. Bayer AG is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. The company's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.
Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Berlex's plans and objectives to differ materially from those expressed or implied in the forward looking statements. Berlex, Inc. undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
* Source: Wolters Kluwer Health, Pharmaceutical Audit Suite, April 2006 - December 2006. Based on total monthly prescription counts from product launch in April 2006 to December 2006, compared to other branded oral contraceptives only.
Web site: www.yaz-us.com
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Posted: January 2007
- Yaz Acne - Treatment for Prevention of Pregnancy, Premenstrual Dysphoric Disorder - October 4, 2006
- Yaz Berlex, Inc. - Treatment for Prevention of Pregnancy - March 17, 2006
- FDA Clarifies Status of Yaz PMDD Application - January 25, 2006
- FDA Extends Review Period of New Drug Application for Oral Contraceptive Yaz to First Quarter 2006 - December 9, 2005
- Berlex Receives Approvable Letter From FDA on the Company's Second Oral Contraceptive Containing Drospirenone - November 18, 2004