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.”
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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