Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Irish pharmaceutical firm Actavis and Medicines360 have received approval from the US Food and Drug Administration (FDA) for Liletta (levonorgestrel-releasing intrauterine system) 52mg for use by women to prevent pregnancy for up to three years.
Subscribe to our email newsletter
The partnership between the firms will allow women, regardless of income and insurance coverage, to access this new and effective contraceptive option.
Liletta is a small, flexible plastic T-shaped system which works to prevent pregnancy by slowly releasing levonorgestrel (LNG), a progestin, at an initial release rate of 18.6mcg/day with an average in vivo release rate of LNG of about 15.6mcg/day over a period of three years.
Liletta, which is intended for use up to three years, is placed in the uterus by a healthcare professional and it can be removed at any time.
Medicines360 chief operating officer Pamela Weir said: "The FDA’s approval of Liletta marks an important milestone for women, providers, and the reproductive health community.
"Liletta was designed from the beginning to be accessible by women, regardless of socioeconomic status.
"In the past, many barriers including expensive upfront costs or lack of insurance coverage have prevented women from obtaining IUDs."
Under the deal, Liletta will be available in the US commercially as well as at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.
The approval was based on the largest hormonal IUD trial, ACCESS IUS, conducted in the US with 1,751 enrolled women receiving Liletta. The trial showed that Liletta was safe and effective for a broad range of women, with a cumulative three year efficacy rate of 99.45%.
The two firms intend to make Liletta available for use in the US by the second quarter of 2015.