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news.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 Israel-based Teva Pharmaceutical's extended-regimen oral contraceptive, Seasonique (levonorgestrel (0.15mg)/ethinyl estradiol (0.03mg) and low-dose ethinyl estradiol (0.01mg) tablets) for the prevention of pregnancy.
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The CHMP concluded that the benefits of Seasonique outweigh its risks clearing the way for the drug’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.
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.
According to the company, the ethinyl estradiol tablets are used during the seven days, instead of a placebo interval, enabling women to have four scheduled periods a year and potentially reducing the withdrawal symptoms that result from a sudden, sharp decrease in hormones.
University of Pavia associate professor of Obstetrics and Gynecology, IRCCS Policlinico San Matteo, and investigator in the Seasonique EU trial Rossella Nappi said Seasonique’s approval will allow physicians to prescribe their patients an oral contraceptive that offers less frequent menses and is both safe and effective.
"Women now starting on oral hormonal contraceptive will be able to choose to have a monthly menstrual period or not," Nappi said.
Teva senior director of Global Marketing Women’s Health Aine Scibelli said the company is happy with the EMA’s CHMP opinion which allows Seasonique to be accessible to more women throughout the world.
"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," Scibelli said.
Seasonique has been available in the US since 2006, and was approved in Chile in November, 2013 and most recently in Brazil in April 2014.