Medicines360 has received the Food and Drug Administration’s blessing to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years.
With this FDA approval, Liletta has one of the longest approved durations of use for a hormonal intrauterine device in the United States.
"As a nonprofit, mission-driven pharmaceutical organization, we are committed to closing critical gaps in women's health care and ensuring that women have access to the medicines and devices they need to live their best and fullest lives," said Tina Raine-Bennett, CEO of Medicines360. "We are proud to study our products in robust clinical trials, like ACCESS IUS, so we can provide quality birth control that works for a broad range of women. The extended duration of use for Liletta continues to provide that women can access a reliable, long-term birth control option that offers greater flexibility and expands choice in their reproductive health decisions."
"Now more than ever, patients need access to safe, long-acting and reversible contraceptive options," said Courtney Schreiber, professor and chief of family planning, department of obstetrics and gynecology at Penn Medicine. "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 healthcare providers the ability to continue offering women a safe and effective option of pregnancy prevention for a long period of time."
Medicines360 received initial approval of Liletta in February 2015. Since then, Medicines360 has continued to invest in the product, which has led to continued optimization of the single-handed inserter and now, the extended duration of use for up to eight years.