FDA Label Update Reflects Bayer’s Commitment to Providing Options for Long-acting Contraception

August 18, 2022 at 08:30 AM EDT

FDA approves extension of Mirena^® (levonorgestrel-releasing intrauterine system) 52 mg Intrauterine Device (IUD) for up to eight years of pregnancy prevention

Bayer, a leader in women's healthcare, announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) that extends the duration of use for its market leadingintrauterine device (IUD) Mirena^® (levonorgestrel-releasing intrauterine system) 52 mg by one more year, making it available to prevent pregnancy for up to eight years.¹

The approval is based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.²

“Now more than ever, it’s important to help ensure that women have the options they need when it comes to contraception needs at various stages of their reproductive life,” stated Yesmean Wahdan, Vice President, U.S. Medical Affairs, Bayer Women’s Healthcare. “A large part of our We’re For Her Mission is helping to ensure education, access, and options. The investment in an 8-year indication will give women who are looking for birth control another option to discuss with their healthcare provider that may meet their needs and personal choice.”

Mirena, the first hormonal IUD to be approved for use in the United States in 2000, was previously approved to prevent pregnancy for up to 7 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 years³ in women who choose intrauterine contraception and can be used in women if they have previously given birth or not. 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.⁴

About the Mirena Extension Trial

The contraceptive effectiveness of Mirena after five years of use was studied in 362 women (The Mirena Extension Trial) and was well tolerated with no new or unexpected safety findings. This trial demonstrated contraceptive efficacy greater than 99% during years 6-8 of use.⁵

INDICATIONS FOR MIRENA

Mirena^® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 8 years. Mirena also treats heavy periods for up to 5 years in women who choose intrauterine contraception.

IMPORTANT SAFETY INFORMATION

If you have a pelvic or 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 provider (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 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 see the accompanying Full Prescribing Information

About Bayer

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 benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

^1-5Data on file. Mirena Product Insert.

Bayer, the Bayer Cross, and Mirena are registered trademarks of Bayer.

Forward-Looking Statements

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.