The U.S. Food and Drug Administration (FDA) has approved Bayer AG’s new low dose levonorgestrel-releasing intrauterine system (LNG-IUS) which will be marketed in the US under the brand name Kyleena™. Kyleena releases the lowest daily dose of the hormone levonorgestrel in an intrauterine system for up to five years of effective protection against pregnancy, using the smallest T-shaped body in an IUS available today. Long-acting contraception is one of the most effective methods of birth control as it does not require user interventions such as daily dosing or monthly re-fills. An LNG-IUS can be removed at any time and offers rapid return to a woman’s natural level of fertility after removal.
“The approval of Kyleena in the U.S. highlights Bayer’s continued commitment to drive innovation and empower women with a broad range of birth control options at different reproductive stages of their lives,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. “Kyleena provides women with an additional reliable and reversible contraceptive option as it does not require daily user intervention to work.”
Unintended pregnancies remain high globally, with 54% of these ending in abortion in developed countries. Unintended pregnancies are particularly high among younger women due to their higher fecundity, compounded by the issue that they frequently do not use their contraceptives correctly (2,3,4,5,6,7,8). Women should talk to their healthcare professional in order to find the most suitable contraceptive method for them within the wide contraceptive portfolio.
The launch of Kyleena in the US is planned for October 2016.
In November 2015 Bayer has also submitted an application for the marketing authorization in the EU for this new low dose levonorgestrel-releasing intrauterine system.
