FDA Approves Bayer’s Kyleena Intrauterine Device

FDA has approved Bayer’s Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg, a progestin-containing intrauterine system for preventing pregnancy for up to five years. Kyleena is a small, flexible plastic T-shaped device containing levonorgestrel 19.5 mg. It is placed by a healthcare provider during an in-office visit. “Because Kyleena slowly releases levonorgestrel into a woman’s uterus, only small amounts of the hormone enter the blood,” Bayer says.

Approval was based on data from a clinical trial that enrolled 1,452 women who received Kyleena. The device’s year one efficacy was based on two pregnancies and the cumulative five-year efficacy rate was based on 13 pregnancies, the company says. About 71% of 163 women who desired pregnancy after study discontinuation and provided follow-up information conceived within 12 months after device removal.