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阿特维斯在美国推出新型避孕装置Liletta,避孕时间长达3年

来源:生物谷 2015-04-16 18:48

2015年4月16日讯 /生物谷BIOON/ --仿制药巨头阿特维斯(Actavis)与非营利女性保健医药公司Medicines360联合宣布,在美国推出Liletta(左炔诺孕酮宫内缓释系统,52mg),这是一款宫内释药避孕装置,用于防止女性受孕,维持时间可长达3年。Liletta由医务人员放置在子宫内,通过连续释放孕激素左炔诺孕酮达到避孕目的。

Liletta是一款新的安全有效的宫内避孕给药装置(IUD),于2015年2月获得FDA批准。Liletta的获批,是基于在美国开展的迄今最大的激素IUD试验ACCESS IUS的数据。该研究调查了Liletta(52mg)的避孕效果及安全性,有1751例女性使用Liletta,数据显示,Liletta持续3年避孕有效率高达99.45%,且使用后女性BMI指数(体重指数)无明显改变。目前,该项研究仍在继续,以评估Liletta使用长达4、5、7年的安全性。

Liletta是一个小型柔性的塑料材质的T形系统,尺寸为32mm×32mm,通过缓慢释放左炔诺孕酮(LNG)发挥避孕作用,LNG初始的释放速率为18.6微克/天,在3年内的平均释放速率为15.6微克/天。

Liletta是一种长效“可逆”的新型激素IUD,适用于许多女性,不论年龄、BMI指数或是否有过生育史。女性可根据自己的需求,随时终止避孕;如需继续避孕,可更换新的Liletta。(生物谷Bioon.com)

英文原文:Actavis and Medicines360 Announce U.S. Availability of LILETTA™ (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Three Years

-LILETTA™ Now Available in Doctors' Offices and Through Public Health Clinics-

DUBLIN and SAN FRANCISCO, April 13, 2015 /PRNewswire/ -- Actavis plc (ACT), a leading global pharmaceutical company and leader in women's health care, and Medicines360, a nonprofit women's health pharmaceutical company, announced today that LILETTA™ (levonorgestrel-releasing intrauterine system) 52 mg is now available in the U.S. for use by women to prevent pregnancy for up to three years.

LILETTA was approved by the U.S. Food and Drug Administration (FDA) on February 26, 2015, based on the largest hormonal IUD trial conducted in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS). LILETTA is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy.

"The availability of LILETTA marks another significant achievement in women's health," said Carolyn Westhoff, MD, M.Sc, Professor, Division Director, Family Planning and Preventive Services, Columbia University Medical Center. "It's critical that women have choices when it comes to their preferred contraception and I am pleased that I can offer my appropriate patients this new safe and effective option."

With the availability of LILETTA, IUD-appropriate women, regardless of financial status and insurance coverage, can now access this new safe and effective IUD through Actavis and Medicines360's partnership. LILETTA is now commercially available in doctor's offices in the U.S. and through this groundbreaking partnership, at a lower price for public health clinics enrolled in the 340B Drug Pricing Program.

"The commercial availability of LILETTA represents a remarkable next step for women's health in the U.S., providing IUD-appropriate women, regardless of income and insurance coverage, with a safe and effective contraceptive option," said Pamela Weir, Chief Operating Officer, Medicines360. "Through this truly innovative partnership, women will now have an accessible, affordable option for effective, long-term contraception."

"Actavis is committed to the continued development and commercialization of safe and effective contraceptives to address unmet needs in women's health," said Bill Meury, President, Actavis Branded Pharma. "LILETTA is a progestin-only intrauterine device with >99% efficacy demonstrated over 3 years. Our groundbreaking partnership with Medicines360 will provide increased access to this novel IUD to women across the private and public healthcare systems in the U.S."

About LILETTA™
LILETTA is a small, flexible plastic T-shaped system which is 32 mm x 32 mm in size. It works to prevent pregnancy by slowly releasing levonorgestrel (LNG), a progestin, at an initial release rate of 18.6 mcg/day with an average in vivo release rate of LNG of approximately 15.6 mcg/day over a period of three years. Generally, LILETTA can be inserted at any time if the provider is reasonably certain that the woman is not pregnant. While LILETTA is intended for use up to three years, it can be removed by a healthcare professional at any time. LILETTA can be replaced at the time of removal with a new LILETTA, if continued contraceptive protection is desired.

About the Clinical Trial for LILETTA
The approval of LILETTA is supported by the largest hormonal IUD trial (ACCESS IUS) conducted in the U.S. designed to reflect the U.S. population. This multicenter open-label clinical trial included 1,751 women aged 16-45 who received LILETTA. In women 16 to 35, LILETTA was found to be 99.45% effective in preventing pregnancy in women regardless of race, parity (previous births), or body mass index (BMI). The trial is ongoing to evaluate the use of LILETTA for up to four, five and seven years.

LILETTA was studied in women aged 16-45, with a 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.

In an analysis of women who discontinued the study early, 97 percent returned to menses within three months after LILETTA was removed. Furthermore, in a group of women (n=68) trying to conceive, 87 percent became pregnant within one year of removal. Additionally, some women were able to conceive as soon as two weeks after removal (12 days). Approximately 19 percent of women treated with LILETTA experienced amenorrhea (absence of menstruation) within one year of treatment and more than one-third experienced amenorrhea by the third year of treatment.

The incidence of ectopic pregnancy in the clinical trial with LILETTA, which excluded women with a history of ectopic pregnancy who did not have a subsequent intrauterine pregnancy, was approximately 0.12 percent per 100 woman-years.

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