FDA approves hormonal IUD for up to 8 years of pregnancy prevention

The FDA approved Medicines360’s Liletta hormonal IUD for up to 8 years of pregnancy prevention, according to a company press release.

The approval was based on additional efficacy and safety data from a phase 3 clinical trial of Liletta 52 mg (levonorgestrel-releasing intrauterine system) with 1,751 women in the United States.

Liletta was previously approved to prevent pregnancy for up to 6 years.

“Now more than ever, patients need access to safe, long-acting and reversible contraceptive options,” Courtney A. Schreiber, MD, MPH, professor and chief of family planning at Penn Medicine in Philadelphia, said in the release. “Liletta is the only hormonal IUD approved for 8 years with a single continuous study for the full duration, providing data for patients and clinicians on the outcomes (high efficacy, low rates of adverse events) with long-term continuous use. This approval gives health care providers the ability to continue offering women a safe and effective option of pregnancy prevention for a long period of time.”