Teva Receives CHMP Positive Opinion for Seasonique® Extended-Regimen Contraceptive for Marketing Authorization in Several European Countries
An Extended Regimen Oral Contraceptive That Provides Quarterly Menses – A New Concept for Women in Europe
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in a referral procedure regarding the authorization of its extended-regimen oral contraceptive, Seasonique® (levonorgestrel (0.15 mg)/ethinyl estradiol (0.03 mg) and low-dose ethinyl estradiol (0.01 mg) tablets) for the prevention of pregnancy. The CHMP concluded that the benefits of Seasonique® outweigh its risks clearing the way for Seasonique®’s approval by local health authorities of the European Union (EU) Member States and launch in select countries throughout Europe by the end of 2014.
“Many women may not be aware that they can space their periods. Seasonique® will offer women a new choice in contraception to achieve greater freedom and confidence in their birth control.”
Seasonique® is an extended regimen birth control option that contains 84 active pills made up of levonorgestrel/ethinyl estradiol and is followed by seven days of ethinyl estradiol tablets. The ethinyl estradiol tablets are used during the seven days, instead of a placebo interval, allowing women to have four scheduled periods a year and potentially lessening the withdrawal symptoms that result from a sudden, sharp decrease in hormones. Seasonique® is backed by extensive clinical trials and real-world experience, and is more than 99 percent effective when taken as directed.
“Seasonique’s approval will allow physicians to prescribe their patients an oral contraceptive that offers less frequent menses and is both safe and effective," noted Rossella Nappi, Associate Professor of Obstetrics and Gynecology, IRCCS Policlinico San Matteo, University of Pavia, Italy and investigator in the Seasonique® EU study. “Women now starting on oral hormonal contraceptive will be able to choose to have a monthly menstrual period or not.”
Data demonstrate that when informed that monthly menses is not medically necessary while on the pill, seven out of 10 women prefer to have fewer periods a year. In fact, a global survey of women in the U.S., Brazil and Germany indicated that a majority of respondents stated a preference to have just four periods a year.
“Teva is pleased with the EMA’s CHMP opinion which allows Seasonique® to be accessible to more women throughout the world,” said Aine Scibelli, Senior Director, Global Marketing Women's Health. “Many women may not be aware that they can space their periods. Seasonique® will offer women a new choice in contraception to achieve greater freedom and confidence in their birth control.”
Seasonique® has been available in the United States since 2006, where it gained 25 percent of the market share within two years, and was approved in Chile on 28 November, 2013 and most recently in Brazil on 14 April, 2014. Upon approval, it is expected to be launched in Austria, Slovakia and Poland with additional country launches to follow.
Seasonique® (levonorgestrel (0.15 mg)/ethinyl estradiol (0.03 mg) and low-dose ethinyl estradiol (0.01mg) tablets) is a 91-day extended-regimen oral contraceptive that contains a combination of female hormones that prevent ovulation. Seasonique® is indicated for the prevention of pregnancy. Seasonique® tablets are taken daily for three months and each subsequent 91-day pack is started the day after the last tablet of the previous pack.
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
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