FDA Approves Medicines360's LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Eight Years

FDA Approval of Extended Duration of Use Supports Medicines360's Mission to Expand Women's Access

SAN FRANCISCO, Nov. 14, 2022 /PRNewswire/ -- Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta® (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years. This approval is based on data from ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS) that Medicines360 first published in the American Journal of Obstetrics and Gynecology in May 2022. With this FDA approval, LILETTA has one of the longest approved durations of use for a hormonal intrauterine device (IUD or IUS) in the U.S.

"As a nonprofit, mission-driven pharmaceutical organization, we are committed to closing critical gaps in women's healthcare and ensuring that women have access to the medicines and devices they need to live their best and fullest lives," said Tina Raine-Bennett, M.D., CEO of Medicines360. "We are proud to study our products in robust clinical trials, like ACCESS IUS, so we can provide quality birth control that works for a broad range of women. The extended duration of use for LILETTA continues to provide that women can access a reliable, long-term birth control option that offers greater flexibility and expands choice in their reproductive health decisions."

FDA approval was based on a review of additional efficacy and safety data from the largest Phase 3 clinical trial of an intrauterine system in the U.S., ACCESS IUS, with 1,751 U.S. women receiving LILETTA. LILETTA was approximately  99% effective in preventing pregnancy for up to eight years in a diverse population of women. The study population in the ACCESS IUS trial included women of various ages, races, and body mass index (BMI).

"Now more than ever, patients need access to safe, long-acting, and reversible contraceptive options," said Dr. Courtney Schreiber, Professor and Chief of Family Planning, Department of Obstetrics and Gynecology, Penn Medicine. "LILETTA is the only hormonal IUD approved for 8 years with a single continuous study for the full duration, providing data for patients and clinicians on the outcomes (high efficacy, low rates of adverse events) with long-term continuous use. This approval gives healthcare providers the ability to continue offering women a safe and effective option of pregnancy prevention for a long period of time."

LILETTA is a hormone-releasing system placed in the uterus to prevent pregnancy for up to eight years. The system should be replaced after eight years if continued use is desired. Medicines360 received initial approval of LILETTA in February 2015. Since then, Medicines360 has continued to invest in the product, which has led to continued optimization of the single-handed inserter and now, the extended duration of use for up to eight years.

LILETTA is commercially available in the U.S., and through Medicines360's nonprofit pharmaceutical model, LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

ABOUT LILETTA^®

INDICATION
LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 8 years.

IMPORTANT RISK INFORMATION

• Do not use LILETTA if you:
  -   Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive
  -   Have a serious pelvic infection called pelvic inflammatory disease (PID); PID occurs in less than 1% of users
  -   Have an untreated lower genital infection now
  -   Have had a serious pelvic infection after an abortion or pregnancy within the last 3 months
  -   Can get infections easily; for example, if you:
• Have problems with your immune system
• Have multiple sexual partners or your partner has multiple sexual partners
• Have a history of PID

-   Have or suspect you might have cancer of the uterus or cervix
-   Have bleeding from the vagina that has not been explained
-   Have short-term (acute) liver disease or liver tumor
-   Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
-   Have an intrauterine contraceptive system (IUS) in your uterus already
-   Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
-   Are allergic to levonorgestrel, silicone, polyethylene, or barium sulfate

• Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain, especially with missed periods, may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection and premature labor or delivery can occur with pregnancies that continue with an IUS
• Although uncommon, pregnancy while using LILETTA can be life-threatening and may result in loss of pregnancy or fertility
• Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop
• Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed
• Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These may be sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy, or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual or foul-smelling vaginal discharge, low abdominal or pelvic pain, painful sex, genital lesions or sores, chills, or fever
• LILETTA may partially go into (become embedded) or go completely through (perforate) the wall of the uterus. If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs. You may need surgery to have LILETTA removed if it is embedded or perforation occurs. Risk of perforation is increased in breastfeeding women
• LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms or do not have sex (vaginal intercourse) until you are seen by a healthcare provider
• Ovarian cysts may occur but usually disappear

LILETTA does not protect against HIV or STDs.

Available by prescription only.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please see full Prescribing Information for LILETTA.

About Medicines360 

Medicines360, located in San Francisco, California, is a global nonprofit women's health pharmaceutical organization with a mission to catalyze equitable access to medicines and devices through product development, policy advocacy, and collaboration with global and US partners. For more information, visit www.medicines360.org

Medicines360® and its design are registered trademarks of Medicines360. All other trademarks are property of their respective owners.

SOURCE Medicines360