Actavis, Medicines360's Liletta IUD gains FDA clearance to prevent pregnancy for up to three years
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By: Katie Bell
Ref: MarketWatch, Daily Mail, PR Newswire
Published: 02/27/2015
Actavis and Medicines360 announced Friday that the FDA approved the Liletta intrauterine device (IUD) for use by women to prevent pregnancy for up to three years. The companies noted that the flexible plastic T-shaped device, which releases the progestin levonorgestrel, will be available in the US by the second quarter.
"Liletta was designed from the beginning to be accessible by women, regardless of socioeconomic status," remarked Pamela Weir, Medicines360's chief operating officer, adding that "in the past, many barriers including expensive upfront costs or lack of insurance coverage have prevented women from obtaining IUDs." The product will be available in the US commercially and at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program, the companies said.
Actavis holds the commercial license for the product, but the marketing application, which was accepted by the FDA last year, was submitted by Medicines360, the holder of US public sector clinic rights. Morningstar analyst Michael WaterHouse said he expected peak global revenues for the product, which is already marketed in Europe, of below $500 million.
The approval was based on data from the ACCESS IUS trial, which enrolled 1751 women, aged 16-45, who received Liletta. The device was found to be safe and effective, with a cumulative three-year efficacy rate of 99.45 percent, regardless of age, parity or body mass index. The study is ongoing, evaluating the use of Liletta for up to four, five and seven years.
A recent report suggested that use in the US of long-acting but reversible methods of birth control, including IUD and sub-dermal implants, increased fivefold between 2002 and 2011-2013.
"Liletta was designed from the beginning to be accessible by women, regardless of socioeconomic status," remarked Pamela Weir, Medicines360's chief operating officer, adding that "in the past, many barriers including expensive upfront costs or lack of insurance coverage have prevented women from obtaining IUDs." The product will be available in the US commercially and at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program, the companies said.
Actavis holds the commercial license for the product, but the marketing application, which was accepted by the FDA last year, was submitted by Medicines360, the holder of US public sector clinic rights. Morningstar analyst Michael WaterHouse said he expected peak global revenues for the product, which is already marketed in Europe, of below $500 million.
The approval was based on data from the ACCESS IUS trial, which enrolled 1751 women, aged 16-45, who received Liletta. The device was found to be safe and effective, with a cumulative three-year efficacy rate of 99.45 percent, regardless of age, parity or body mass index. The study is ongoing, evaluating the use of Liletta for up to four, five and seven years.
A recent report suggested that use in the US of long-acting but reversible methods of birth control, including IUD and sub-dermal implants, increased fivefold between 2002 and 2011-2013.