U.S. FDA approves Bayer contraceptive device Kyleena

(Reuters) - The U.S. Food and Drug Administration approved Bayer AG’s hormonal contraceptive device, Kyleena, to prevent pregnancy for up to five years, the German company said on Monday.

The small, flexible plastic T-shaped intrauterine device (IUD) releases the hormone levonorgestrel that stops the womb lining from thickening, which in turn prevents pregnancy.

Kyleena, which will be available from October, is a long-acting reversible contraceptive (LARC), a category of potent contraceptives that has returned to popularity.

LARCs, including IUDs and implants, are more effective than other contraceptives such as pills and patches, and are nearly as effective as sterilization, according to the U.S. Centers for Disease Control and Prevention.

Hormonal IUDs such as Kyleena are marginally more effective than commonly used copper IUDs, such as Teva Pharmaceutical Industries Ltd’s Paragard, which last longer but do not help control blood flow.

After using Kyleena for a while, women are likely to experience fewer days of bleeding and spotting, while periods will stop altogether for some, Bayer said.

Kyleena adds to a suite of Bayer hormonal IUDs, including Mirena and Skyla.

The FDA in February 2015 also approved Liletta, a hormonal IUD made by Actavis Plc, now known as Allergan Plc. Liletta is approved to prevent pregnancy for up to three years. (

Reporting by Natalie Grover and Akankshita Mukhopadhyay in Bengaluru; Editing by Savio D’Souza