Bayer’s Skyla Receives FDA Approval
The Food and Drug Administration (FDA) have given approval to the new long-term contraceptive, Skyla, Bayer announced yesterday.
Regulators in the USA have given the green light to Skyla, a low-dose levonorgestrel-releasing intrauterine system (IUS). The small, flexible plastic T-shaped device, which contains 13.5 mg of the progestin hormone, is positioned in the uterus for the prevention of pregnancy for up to three years.
The approval is 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 contraceptive, the first new device of its type in 12 years, is over 99% effective in preventing pregnancy and was generally well tolerated.
As Skyla gradually releases levonorgestrel, only small amounts of the hormone enter the blood. During the initial three to six months of using the contraceptive, women might experience irregular periods and a rise in the number of bleeding days. Women may also have repeated spotting or light bleeding. After using Skyla for a while, the number of bleeding and spotting days is likely to decline, and there is a small chance that periods may stop altogether.
Bayer HealthCare’s head of global development, Kemal Malik, commented “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.”
Skyla is proposed for long-term use of up to three years but can be removed by a healthcare provider at any time. Women may become pregnant as soon as Skyla is removed, so should use an alternative method of birth control if they do not wish to become pregnant. Roughly 77% of women who want to become pregnant became pregnant sometime during the first year after Skyla is removed.
Last month, European regulators gave the approval to Skyla which will be marketed as Jaydess. Bayer already sells a levonorgestrel-releasing IUS, called Mirena.