Regulators in the USA have given the green light to Bayer's new long-term contraceptive Skyla.
The US Food and Drug Administration has approved Skyla, its low-dose levonorgestrel-releasing intrauterine system (IUS). The small, flexible plastic T-shaped device is placed in the uterus for the prevention of pregnancy for up to three years.
The approval is 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 Skyla, the first new device of its type in 12 years, is more than 99% effective in preventing pregnancy and was generally well tolerated.
Kemal Malik, head of global development at Bayer HealthCare. said "we are pleased to provide women who are seeking contraception with a new and effective option to consider with their healthcare providers in the USA".
Last month, regulators in Europe gave the thumbs-up to the device which will be marketed as Jaydess. Bayer already sells a levonorgestrel-releasing IUS, namely Mirena.