Bayer seeks marketing approval for new five-year contraceptive in US and Europe

22 November 2015 (Last Updated November 22nd, 2015 18:30)

Bayer has submitted new drug applications (NDAs) to seek marketing authorisation in the European Union (EU) and the US for LCS-16, an investigational hormonal intrauterine device (IUD) for pregnancy protection for up to five years.

Bayer has submitted new drug applications (NDAs) to seek marketing authorisation in the European Union (EU) and the US for LCS-16, an investigational hormonal intrauterine device (IUD) for pregnancy protection for up to five years.

LCS-16 is a new low-dose levonorgestrel-releasing intrauterine system (LNG-IUS) which is directly placed in the uterus for birth control.

Once placed in the uterus, LCS-16 releases a low dose of the progestogen levonorgestrel directly into the uterus and provides effective birth control for up to five years.

The company noted LNG-IUS can be removed at any time and offers a rapid return to a woman's usual level of fertility after removal.

The NDAs are based on data from Phase III clinical trials, which included 574 nulliparous and 878 parous women from North America and several European countries.

"As a leader in women's healthcare, we are committed to continuously advance our portfolio of innovative contraceptive methods to meet the needs of a broad range of women."

Data from these trials showed that LCS-16 is highly effective and well tolerated regardless of age and parity. The primary endpoint of the Phase III clinical trial programme was contraceptive efficacy evaluated by the Pearl index.

The data also showed the new IUS is more than 98.5% effective in preventing pregnancy.

Bayer HealthCare executive committee member Dr Jorg Moeller said: "As a leader in women's healthcare, we are committed to continuously advance our portfolio of innovative contraceptive methods to meet the needs of a broad range of women.

"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 authorisation 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."

The small, flexible plastic T-shaped device, LCS-16, was generally well tolerated, with no unexpected adverse events reported.