Bayer Submits sNDA to FDA Seeking Extension of Mirena® IUD Contraceptive Use to Seven Years

October 15, 2020 /BioValleyBIOON/ --Bayer(Bayer) is a leader in women’s health. The company recently announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) submitted a supplemental New Drug Application (sNDA) to extend the duration of use for its market-leading intrauterine device (IUD), Mirena (Chinese brand name: Manyue Le; levonorgestrel-releasing intrauterine system) 52 mg.

This August, Mirena receivedFDAApproval was granted to extend the continuous use duration of this product for pregnancy prevention (contraception) to six years. The sNDA submitted herein seeks to extend the approved duration by an additional year, based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena, thereby allowing up to seven years of pregnancy prevention.

Edio Zampaglione, M.D., Vice President of Medical Affairs for Women’s Healthcare at Bayer, stated, “For more than 50 years, Bayer has been committed to providing women with a diverse range of products to meetReproductive Healthand contraceptive needs. This new proposal demonstrates Bayer’s commitment to further investing in the field of women’s health.”

Mirena was approved by the U.S. FDA in 2020 and is the first hormonal intrauterine device (IUD) approved for use in the U.S. market. It has been approved to prevent pregnancy for up to 6 years by releasing a small amount of the progestin hormone levonorgestrel into the uterus. The product is also the only oneFDAAn intrauterine device (IUD) approved for up to five years of treatment for heavy menstrual bleeding in women who choose intrauterine contraception, regardless of prior childbirth status. Mirena is a long-acting reversible contraceptive (LARC) that can be removed by healthcare providers at any time if a woman’s plans change.

Mirena (levonorgestrel-releasing intrauterine system) 52 mg is indicated for contraception for up to 6 years; replacement is required after the sixth year. For women who have chosen an intrauterine device as their method of contraception, Mirena is also indicated for the treatment of heavy menstrual bleeding for up to 5 years; if continued treatment for heavy menstrual bleeding is required, replacement is necessary after the fifth year.

Mirena (Levonorgestrel-releasing intrauterine system) is a small, flexible T-shaped device that slowly releases progestin within the uterine cavity. Approved in China in 1998 for contraception and idiopathic menorrhagia, it has been used by over 100 million women worldwide. This June, the National Medical Products Administration (NMPA) approved an update to Mirena’s indications: “Menorrhagia. For patients with structural menorrhagia, primary underlying conditions should be treated first.” Mirena provides an effective non-surgical option for the treatment of menorrhagia. (Bioon.com)

Original Source: Bayer Submits Supplemental New Drugapplication to FDA for Intrauterine Device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg