Bayer announced the submission of a supplemental New Drug Application to the Food and Drug Administration (FDA) for the intrauterine device (IUD), Mirena (levonorgestrel-releasing intrauterine system) 52mg, to extend the indication to up to 6 years of pregnancy prevention. Currently, it is indicated for contraception for up to 5 years.

The application is supported by data from the phase 3 MET (Mirena Extension Trial) study that assessed the contraceptive efficacy and safety of Mirena in women aged 18 to 35 years beyond 5 years of use.

“Contraception is a very personal decision that is based on a woman’s individual needs, and Bayer is committed to developing options that can be tailored to a woman’s unique life plans,” said Edio Zampaglione, MD, Bayer’s VP of medical affairs for Women’s Healthcare. “This submission demonstrates Bayer’s commitment to investing and innovating in the field of women’s health.”

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Mirena is also indicated for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. 

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