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FDA approves Liletta to prevent pregnancy for up to 4 years

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The FDA recently approved Liletta 52 mg for the extended use of up to 4 years for the prevention of pregnancy, according to a recent press release issued by Allergan and Medicines360.

Liletta (levonorgestrel-releasing intrauterine system) was first approved by the FDA in February 2015 and then again in January 2016 for the single-handed inserter, according to the release.

“The newly approved indication for Liletta is an important milestone in our work to make this [intrauterine device (IUD)] available to women, in partnership with Allergan,” Jessica Grossman, MD, CEO of Medicines360, said in the release. “Our mission is to help women access safe and effective contraception, and the new 4-year indication for Liletta is good news for women who want the reliability and flexibility that a hormonal IUD can offer.”

The FDA based its most recent approval on a data from an ongoing phase 3 hormonal IUD trial, ACCESS IUS, according to the release. The investigators reviewed the safety and efficacy of Liletta in 1,751 women from the United States and found that Liletta was more than 99% effective in prevention of pregnancy in women regardless of age, race, BMI or parity, according to the release.

“Allergan is committed to advancing options in women’s health care, and we are pleased to partner with Medicines360 to further our common goal to offer women effective and safe contraceptives,” David Nicholson, PhD, chief research and development officer at Allergan, said in the release. “The FDA’s approval of an extended indication for Liletta is another step forward for women’s reproductive health options.”

Liletta is commercially available throughout the United States and at a lower cost for public health clinics participating in the 340B Drug Pricing Program, according to the release.

“IUDs are among the safest and most effective forms of contraception and are a critical tool in reducing unintended pregnancy,” David Turok, MD, MPH, from the department of obstetrics and gynecology at the University of Utah, said in the release. “As a clinician, I appreciate that the clinical trial demonstrated Liletta’s safety and efficacy across a wide range of women, regardless of age, BMI and ethnicity.”

Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.