FDA extends the use of Bayer’s IUD for up to eight years

The German multinational pharmaceutical and biotechnology company has announced the Food and Drug Administration (FDA) approval for a supplemental new drug application that extends the duration of use for its intrauterine device (IUD) by one more year, making it available to prevent pregnancy for up to eight years.

The approval is based on results from a phase three extension trial evaluating the efficacy and safety of Mirena.

“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,” says Yesmean Wahdan, medical affairs vice president at 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 eight-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 US in 2000, was previously approved to prevent pregnancy for up to seven years by releasing small amounts of progestin hormone called levonorgestrel into the uterus.

It is the only FDA-approved IUD to treat heavy periods for up to five years in women who choose intrauterine contraception and can be used in women who have not previously given birth.

According to Bayer, the contraceptive effectiveness of Mirena after five years of use was studied in 362 women and was well tolerated with no new or unexpected safety findings.

The company’s trial has demonstrated contraceptive efficacy greater than 99 per cent during years six to eights years of use.