Actavis Hormonal IUD Wins FDA Approval

The US Food and Drug Administration has approved the hormonal intrauterine contraceptive (IUD) Lileta, which releases the hormone levonorgestrel to inhibit thickening of the womb lining, preventing pregnancy for up to three years.

Ireland-based Actavis holds the commercial license for the product, which also helps to check heavy menstrual bleeding, but the marketing application was submitted by non-profit pharmaceutical company Medicines360, which holds the US public sector clinic rights.

The companies expect the device, already in use in Europe, to be available in the US shortly. Hormonal IUDs generally are marginally more effective than commonly used copper IUDs, such as Teva's Paragard, which last longer but provide no control of blood flow.

Liletta will compete in the $1 billion global market for IUD along with Bayer's hormonal IUDs Mirena and Skyla in the US. In a trial evaluating Liletta's use for up to seven years, the device is being tested in the largest-ever US trial for IUDs.

Long-acting reversible contraceptives (LARCs) have returned to popularity over the past decade as more potent devices hit the market. These are more effective than other contraceptives such as pills and patches and are nearly as effective as sterilization, according to the US Centers for Disease Control and Prevention (CDC).