Bayer has announced that the U.S. Food and Drug Administration (FDA) approved 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 year, making it available to prevent pregnancy for up to seven years. The approval is based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.
“Aligned to our mission We’re For Her, Bayer continues to take bold steps to advance women’s health. Providing a 7 year contraceptive option is an exciting milestone and another example of our commitment to women, so that they have more options to discuss with their healthcare professionals to help them live their lives on their own terms,” said John Berrios, Senior Vice President, Bayer Women’s Healthcare.
Mirena, the first hormonal IUD to be approved for use in the United States in 2000, is currently approved to prevent pregnancy for up to 6 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 whether they have previously given birth. 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.
