- Source : Business Wire
- Date : 2021-08-25
- Event type : Approved
- Companies : Bayer AG
FDA Label Updates Reflect Bayer's Commitment to Women's Healthcare
FDA approves extension of Intrauterine Device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg for up to seven years of pregnancy prevention
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer, a leader in women's healthcare, today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) that extends the duration of use for its market leading1 intrauterine device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg by one year, making it available to prevent pregnancy for up to seven years. The approval is based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.2
“Aligned to our mission We're For Her, Bayer continues to take bold steps to advance women's health. Providing a 7 year contraceptive option is an exciting milestone and another example of our commitment to women, so that they have more options to discuss with their healthcare professionals to help them live their lives on their own terms," said John Berrios, Senior Vice President, Bayer Women's Healthcare.
Mirena, the first hormonal IUD to be approved for use in the United States in 2000, is currently approved to prevent pregnancy for up to 6 years by releasing small amounts of progestin hormone called levonorgestrel into the uterus. It also is the only FDA-approved IUD to treat heavy periods for up to 5 years in women who choose intrauterine contraception and can be used in women whether they have previously given birth. Mirena is a long-acting reversible contraceptive (LARC) and can be removed at any time by a healthcare provider if a woman's plans change.3
“It's important that women know their options across all stages of their reproductive life planning to have informed conversations with their providers regarding their long-term contraception needs,” stated Yesmean Wahdan, M.D., Vice President, U.S. Medical Affairs, Bayer Women's Healthcare.
INDICATIONS FOR MIRENA
Mirena® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 7 years. Mirena also treats heavy periods for up to 5 years in women who choose intrauterine contraception.
IMPORTANT SAFETY INFORMATION
- If you have an untreated genital infection, get infections easily, or have certain cancers, don't use Mirena. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID).
- If you have persistent pelvic or stomach pain, or excessive bleeding after placement, tell your healthcare professional (HCP). If Mirena comes out, call your HCP, and avoid intercourse or use non-hormonal back-up birth control (such as condoms or spermicide). Mirena may go into or go through the wall of the uterus and cause other problems.
- Pregnancy while using Mirena is uncommon but can be life threatening and may result in loss of pregnancy or fertility.
- 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.
Mirena does not protect against HIV or STIs.
Only you and your HCP can decide if Mirena is right for you. Mirena is available by prescription only.
For important risk and use information about Mirena, please click here to see the Full Prescribing Information
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.us.
1 Supported by 2020 Symphony Health medical claims data on long-term reversible contraceptive (LARC) market. Data on file.
2 https://clinicaltrials.gov/ct2/show/NCT02985541. Accessed October 14th, 2020.
3 Data on file. Mirena Product Insert.
Bayer, the Bayer Cross, and Mirena are registered trademarks of Bayer.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
PP-MIR-US-0365-1- August 2021