Bayer Mirena gets USFDA nod for extended use as contraceptive
LNG-IUS is one of the most effective birth control methods as it does not require user interventions such as daily dosing or monthly re-fills.
Berlin: Bayer, has announced that the supplemental New Drug Application (sNDA) for the extended use up to eight years in the indication, contraception was approved for its levonorgestrel (LNG) releasing intrauterine system (IUS) Mirena by the U.S. Food and Drug Administration (USFDA). This approval is based on the results of the Mirena Extension Trial evaluating the efficacy and safety of Mirena which demonstrated that contraceptive efficacy during years six to eight remains high.
Mirena is a T-shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small amounts of levonorgestrel directly into the uterus.
"This label extension underlines Bayer's continued commitment to drive innovation in the area of women's healthcare and to offer women a broad variety of contraceptive methods during their reproductive life", said Dr. Michael Devoy, Chief Medical Officer at Bayer AG. "As every woman is different, the personal decision for a specific contraceptive option is taken on the individual needs of a woman in close consultation with her healthcare professional."
The duration of use for the second approved indication in the US (heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception) remains unchanged for up to five years.
At the beginning of 2022, Bayer also submitted the eight-year label extension for the indication contraception in the EU for the LNG-IUS Mirena.
LNG-IUS is one of the most effective birth control methods as it does not require user interventions such as daily dosing or monthly re-fills. It can be removed by the doctor at any time and offers a rapid return to a woman's natural level of fertility after removal. An LNG-IUS should only be inserted after a comprehensive discussion and evaluation of all contraceptive options and the individual woman's needs.
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