FDA approves Liletta to prevent pregnancy for up to 6 years
The FDA approved a supplemental new drug application for the hormone-releasing intrauterine device Liletta 52 mg that extends the device’s duration for pregnancy prevention for a maximum of 6 years, according to a press release.
Liletta (levonorgestrel-releasing intrauterine system, Medicines360) received the approval after an FDA review of phase 3 trial data that showed the device was more than 99% effective among its 1,751 participants who came from various ages, BMI and races. The approval marks the longest approved duration of use for a hormonal intrauterine device in the United States, the release continued.
“I hear all the time from women that they want a reliable and long-term option for birth control that is reversible,” Carolyn Westhoff, MD, MSC, chief of the division of family planning, at Columbia University, said in the release. “This groundbreaking trial has given health care providers the ability to confidently offer women the option of pregnancy prevention for up to 6 years.”
The release cautioned that some should not use Liletta, including those women who are or think they might be pregnant. A full list of those who should not use the device is available at www.liletta.com.
The FDA’s first approval of Liletta came in 2015, when the agency approved the device’s use for up to 3 years. Subsequent approvals and trials have also shown Liletta to be effective at 4 and 5 years.
Disclosures: Westhoff was an investigator on a Liletta trial.