Allergan Partners with U.S. Women’s Health Alliance Increasing Access to LILETTA 52 mg

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The FINANCIAL — Allergan plc  and U.S. Women’s Health Alliance (USWHA), an organization focused on promoting high-quality, affordable healthcare for women, announced an agreement to make LILETTA (levonorgestrel-releasing intrauterine system) 52 mg available to patients across USWHA’s 26 Alliance health care groups nationwide.

The agreement paves the way for 1,500 Alliance physicians to offer LILETTA as a contraceptive option to the millions of reproductive-age women that they care for across the country, according to Allergan.

“As a leader in women’s healthcare, the U.S. Women’s Health Alliance believes in offering safe, effective treatment options to our patients, and the IUD is among the most efficacious forms of contraception on the market,” said Jack Feltz, MD, President of USWHA and President/CEO of Lifeline Medical Associates, LLC in New Jersey. “The range of women studied in the LILETTA Phase 3 clinical trial is representative of the diverse population of women treated by our physicians throughout the United States.”

LILETTA received marketing approval from the U.S. Food and Drug Administration (FDA) in February 2015, supported by the largest hormonal IUD trial (ACCESS IUS) conducted in the U.S. designed to reflect the U.S. population. This multi-center, open-label clinical trial included 1,751 women who received LILETTA.  LILETTA was studied in women aged 16-45, with a body mass index (BMI) range of 15.8kg/m2 – 61.6kg/m2 (26.9 kg/m2 mean BMI) across women of various races and ethnicities. Most women were Caucasian (78.4 percent) or Black/African American (13.3 percent); 14.7 percent of women were of Hispanic ethnicity. Nearly 58 percent of trial participants were nulliparous (had not previously given birth), the largest percentage of nulliparous IUD patients ever studied.    LILETTA was found to be 99.45 percent effective in preventing pregnancy in women regardless of age, parity (previous births), or BMI for up to 3 years.    The trial is ongoing to evaluate the use of LILETTA for up to four, five, and seven years.

“When barriers such as cost, education and access are removed, more women choose IUDs,” said Herm Cukier, Vice President, Women’s Healthcare at Allergan. “By partnering with the U.S. Women’s Health Alliance, we have increased our ability to effectively reach IUD-appropriate women across the country and offer LILETTA as a potential contraceptive option.”

Since the product became available for customers in April 2015, clinics in all 50 states have ordered LILETTA, with thousands of women treated during the past several months. LILETTA is currently available in a number of U.S. Women’s Health Alliance practices. 


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