LILETTA® levonorgestrel-releasing intrauterine system now FDA-approved for use for up to 6 years
Post written by Yadurshini Raveendran, FHI 360
Medicines360 and Allergan announced the U.S. Food and Drug Administration (FDA) approved the extension of LILETTA® (levonorgestrel-releasing intrauterine system, LNG-IUS) for pregnancy prevention for up to 6 years, making it the longest duration LNG-IUS and second longest reversible contraceptive in the U.S.
The FDA approval was based on a review of additional efficacy and safety data from an ongoing Phase 3 clinical trial of 1,751 U.S. women receiving LILETTA®. LILETTA® proved to be more than 99 percent effective in preventing pregnancy for up to 6 years in a diverse population of women that included women of various ages, races, and body mass index. This news of the approval of LILLETTA® for up to six years is a step towards providing women with greater flexibility and agency when it comes to their sexual and reproductive health.
Earlier in October, Bayer announced submission of a supplemental new drug application to the FDA seeking to potentially extend the duration of their LNG-IUS, Mirena®, for up to 6 years as well. Mirena® was the first LNG-IUS approved in the U.S., currently for up to 5 years.
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