Bayer has received approval from the U.S. Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) that extends the duration of use for its intrauterine device (IUD) Mirena (levonorgestrel-releasing intrauterine system) 52 mg by one more year, making it available to prevent pregnancy for up to eight years. The approval is based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.
Yesmean Wahdan, Vice President, U.S. Medical Affairs, Bayer Women’s Healthcare explains: “Now more than ever, it’s important to help ensure that women have the options they need when it comes to contraception needs at various stages of their reproductive life. A large part of our We’re For Her Mission is helping to ensure education, access, and options. The investment in an 8-year indication will give women who are looking for birth control another option to discuss with their healthcare provider that may meet their needs and personal choice.”
The hormonal IUD Mirena was first approved for use in the United States in 2000, and was previously approved to prevent pregnancy for up to 7 years by releasing small amounts of progestin hormone called levonorgestrel into the uterus. It also is the only FDA-approved IUD to treat heavy periods for up to 5 years in women who choose intrauterine contraception and can be used in women if they have previously given birth or not. Mirena is a long-acting reversible contraceptive (LARC) and can be removed at any time by a healthcare provider if a woman’s plans change.
The contraceptive effectiveness of Mirena after five years of use was studied in 362 women (The Mirena Extension Trial) and was well tolerated with no new or unexpected safety findings. This trial demonstrated contraceptive efficacy greater than 99% during years 6-8 of use.