Bayer submits its new five-year-contraceptive for EU and US marketing Authorization

Bayer has submitted an application for marketing authorization in both the European Union and in the United States for LCS-16, a new low-dose levonorgestrel-releasing intrauterine system (LNG-IUS) which is directly placed in the uterus for contraception for up to five years.

Long-acting contraception is one of the most effective methods of birth control. An LNG-IUS can be removed at any time and offers rapid return to a woman’s usual level of fertility after removal.

Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development said: “An intrauterine system does not only bring the advantage that women do not have to think about their contraception every day, but also that it contains fewer hormones than other hormonal contraceptive options like the pill or implant.”

“With the application for marketing authorization for LCS-16, we hope we will be able to offer women an additional option of a reliable and convenient long-acting reversible contraception that contains the lowest available dose of hormones for up to five years.”

Data from Phase III clinical trials, including 574 nulliparous and 878 parous women from North America and several European countries have demonstrated that LCS-16 is highly effective and well tolerated regardless of age and parity. The primary endpoint of the Phase III clinical trial program was contraceptive efficacy assessed by the Pearl index.

The data showed that the new IUS is more than 98.5 percent effective in preventing pregnancy. Moreover, LCS-16 was generally well tolerated, with no unexpected adverse events reported. Low incidences of ectopic pregnancy, pelvic inflammatory disease, expulsion of the device from the uterus and uterine perforation were seen.