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Bayer’s Jaydess Approved in Europe
Posted on December 5, 2012 by Elysia Robinson
European regulators have approved Bayer’s new long-term contraceptive, Jaydess, which offers women the opportunity to prevent pregnancy for up to three years.
The German organisation confirmed that they have successfully completed the European registration procedure for their new low-dose levonorgestrel-releasing intrauterine system (IUS).
The small, flexible plastic T-shaped device is positioned in the uterus and has been created for women “who are looking for a reliable, convenient long-term contraceptive option with a very low hormonal dose,” commented Kemal Malik, head of global development at Bayer HealthCare.
In comparison to oral contraceptives, the new IUS is a contraceptive option for women who do not want to take a pill every day, and provides a speedy return to a woman’s usual level of fertility after removal, the business noted.
The approval was founded on a Phase III clinical trial of 1,432 women aged 18-35, of which 39% had not yet had a child. The results demonstrated that the new IUS is more than 99% effective in preventing pregnancy and the drug was generally well tolerated.
Sweden served as the reference member state for the decentralised procedure to gain Europe-wide marketing authorisation for Jaydess and the initial launches are expected to take place in the second quarter of 2013. Jaydess was filed in the USA in December 2011.