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Mirena levonorgestrel-releasing intrauterine system now approved for 6 years of pregnancy prevention

The United States Food and Drug Administration (FDA) approved Mirena® for an additional year of duration, extending its indication for up to six years of pregnancy prevention. Mirena® is a levonorgestrel-releasing intrauterine system (hormonal IUS) produced by Bayer HealthCare Pharmaceuticals, classified as a long-acting reversible contraceptive (LARC). Mirena® contains 52mg of levonorgestrel (LNG), which initially releases at a rate of approximately 20mcg LNG per day. Although this rate decreases progressively to approximately 10mcg/day after 5 years and 9mcg/day after 6 years, evidence demonstrated this dose is still highly effective at preventing pregnancy.

The FDA’s approval of the supplemental New Drug Application (sNDA) was based on data from the Phase 3 Mirena Extension Trial, conducted with 362 women ages 18-35 years. Results showed efficacy of Mirena® beyond five years, using a primary end point of pregnancy rate, calculated as the Pearl Index at the end of year 6.

In addition to pregnancy prevention, Mirena® is also indicated for the treatment of heavy menstrual bleeding, which is one of the method’s potential non-contraceptive side benefits.

Last year, the FDA approved LILETTA®, a hormonal IUS produced by Medicines360 and Allergan, for up to six years of pregnancy. The approval of both of these methods for six years is an encouraging step, allowing contraceptive users more cost-effective options and greater agency over their reproductive health.

Read more about the sNDA approval here.

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