FDA Approves Medicines360’s Supplemental New Drug Application for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg as Treatment of Heavy Menstrual Bleeding

New Indication Expected to Increase Treatment Options of Heavy Menstrual Bleeding for up to five years in patients who choose intrauterine contraception as their method of contraception

July 10, 2023

SAN FRANCISCO, CA– Medicines360, a global nonprofit organization with a mission to catalyze equitable access to quality medicines for women, announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for treatment of Heavy Menstrual Bleeding (HMB) for up to five years in patients who choose intrauterine contraception as their method of contraception.

A substantial body of literature has demonstrated the levonorgestrel 52 mg IUS to be highly effective at reducing bleeding in patients with HMB. “For those experiencing HMB, medical

treatments are preferred over surgical treatment as they are more convenient and pose less risk,” said Andrea Olariu, M.D., PhD, and CEO of Medicines360. “With limited choices of hormonal IUDs to treat HMB, we are pleased to deliver on our mission by working to offer prescribers and patients another medical treatment option.”

The FDA’s approval of the new indication is based on efficacy and safety data from a Phase 3 clinical trial conducted by Medicines360, which was first published in Obstetrics and Gynecology in May 2023. The clinical trial included study participants of various ages, races, parity, and body mass index (BMI).

LILETTA is commercially available in the U.S. 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 INDICATIONS

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. LILETTA also treats heavy periods for up to 5 years in women who choose to use birth control placed in the uterus.

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
  • 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
  • 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

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.

Please see full Prescribing Information for LILETTA.

Press Contact: Stacey Manley

Vice President, Communications & Marketing smanley@Medicines360.org                                415.951.8700

About Medicines360

Located in San Francisco, California, Medicines360 is a global nonprofit pharmaceutical organization with a mission to accelerate the timeline from health innovation to access for all women. Medicines360 is committed to working with healthcare providers, advocacy groups, and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org.

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  75. Lucia
  76. Vincent & the Grenadines
  77. Sudan
  78. Swaziland
  79. Tanzania
  80. Thailand
  81. The Gambia
  82. Timor-Leste
  83. Togo
  84. Tunisia
  85. Uganda
  86. Vietnam
  87. Zambia
  88. Sri Lanka

Tina Raine-Bennett, MD, MPH, FACOG

Chief Executive Officer

Tina Raine-Bennett, MD, MPH, is CEO of Medicines360. Previously, she served as a senior research scientist at the Kaiser Permanente Northern California Division of Research and the research director of the Women’s Health Research Institute. She is a Board-Certified Obstetrician Gynecologist who received her medical training at the University of California, San Diego, and post-graduate residency training and MPH at the University of Washington in Seattle, where she also completed a Robert Wood Johnson Clinical Scholars Fellowship. She was also senior staff physician at Kaiser Permanente and has a special interest in family planning and adolescent reproductive health.

As the director of the Women’s Health Research Institute, Dr. Raine-Bennett focused on expanding research on women’s health within the Division and translating women’s health research into clinical practice and policy within the Ob/Gyn departments in Northern California. She also promoted the involvement of clinicians in research designed to improve the health outcomes and healthcare experiences of women at Kaiser Permanente and women in general.

Prior to Kaiser Permanente, Dr. Raine-Bennett was a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Francisco (UCSF). She was based at San Francisco General Hospital where she was also the medical director of the New Generation Health Center, a UCSF affiliate site that provides community-based reproductive health services. Dr. Raine-Bennett’s research has focused on contraceptive methods and on elucidating factors that influence contraceptive choice and continuation, and she was principal investigator on NIH grants to assess hormonal contraceptive use predictors and develop interventions to improve contraceptive access.

Her past and current research on emergency contraception has focused on the safety of making emergency contraception more accessible and she conducted a pivotal clinical trial to make emergency contraception available to teens without a prescription. She served on the editorial board of Obstetrics and Gynecology and has over 100 peer-reviewed publications. She was the Treasurer of the Board of Directors for the Society of Family Planning and Society of Family Planning Research Fund. She has also served as an examiner for the American Board of Obstetrics and Gynecology, and on national committees for the American College of Obstetrics and Gynecology and the National Medical Board of Planned Parenthood Federation of America.