Bayer has been given the green light by Europe's regulator to market its new long-term contraceptive Jaydess which provides prevention of pregnancy for up to three years.
The German group says it has successfully concluded the European registration procedure for its new low-dose levonorgestrel-releasing intrauterine system (IUS). The small, flexible plastic T-shaped device is placed in the uterus and has been developed for women "who are looking for a reliable, convenient long-term contraceptive option with a very low hormonal dose", said Kemal Malik, head of global development at Bayer HealthCare.
The approval was based on a Phase III trial of 1,432 women aged 18-35, of which 39%, had not yet had a child. The data showed that the new IUS is more than 99% effective in preventing pregnancy and was generally well tolerated.
Sweden served as the reference member state for the decentralised procedure to gain EU-wide marketing authorisation for Jaydess and first launches are expected in the second quarter of 2013. The product was filed in the USA in December 2011.