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Bayer awaits FDA decision on new contraceptive

pharmafile | November 20, 2015 | News story | Medical Communications, Research and Development |   

Bayer has submitted a new drug application (NDA) to the FDA, seeking approval for LCS-16, an investigational hormonal intrauterine device (IUD) that it says can provide pregnancy protection for up to five years.

The submission is based on data from the Phase III clinical trials which included 574 nulliparous (never borne offspring) and 878 parous (having borne offspring) women from North America and several European countries. The primary endpoint of the Phase III clinical trial program was contraceptive efficacy assessed by the Pearl Index, which rates the effectiveness of birth control methods.

Dario Mirski, vice president and head of US medical affairs at Bayer, says: “As a global leader in women’s healthcare, Bayer is committed to the continuous advancement of our portfolio of contraceptive methods to help meet the needs of a broad range of women. With this submission, we hope to offer women an additional long-acting reversible contraception for up to five years.”

LCS-16 is an investigational intrauterine device (IUD) containing 19.5 mg of a progestin hormone called levonorgestrel.

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The drug is not currently approved in any country; however, an application for marketing authorisation for LCS-16 was submitted to the European Medicines Agency (EMA) earlier this month for approval of the same indication in the European Union.

Yasmita Kumar

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