新型避孕装置LILETTA(levonorgestrel-releasing)获美国FDA批准,用于防止女性受孕，维持时间可长达5年.

2018年10月18日，美国食品和药物管理局（FDA）已批准Liletta（左炔诺孕酮宫内缓释系统，52mg）的一份补充新药申请（sNDA），将该产品用于预防妊娠的持续使用时间延长至5年。
  Liletta是一款安全有效的宫内释药避孕装置（IUD），最初于2015年2月获批用于防止女性受孕，之前已获批的持续使用时间为4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。
  此次sNDA的批准，是基于在美国开展的迄今最大的宫内系统（IUS）III期临床研究ACCESS IUS的额外疗效和安全性数据，共有1751例女性使用了Liletta避孕。数据显示，Liletta在广泛的女性群体中使用持续5年的时间内避孕有效率超过99%，且使用后女性BMI指数（体重指数）无明显改变。
  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。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、种族、BMI指数或生育史（无论女性是否生过至少一个孩子）。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。
New LILETTA Single Handed IUD Inserter Unveiled to Improve Birth Control Options
Allergan, a well known pharma firm, and Medicines360, a nonprofit pharma firm focusing on women’s issues, are releasing the new LILETTA (levonorgestrel-releasing intrauterine system) 52 mg intrauterine device single-handed inserter.
lilettaThe tool was designed to make the placement of an IUD more consistent and easier due to its one-handed operation, which can be done using either the left or right hand. The tube that’s inserted is bendable and will conform to patient anatomy as it’s pushed toward the uterus.
The device is reloadable if placement proves challenging and it comes down to trying it again.
Some details according to a Medicines360 announcement:
The approval of the new single-handed inserter was based on the largest hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), conducted in the U.S. with 1,751 enrolled women receiving LILETTA, the same trial that supported the initial approval of LILETTA. LILETTA was shown to be safe and effective for a broad range of women, with a cumulative three-year efficacy rate of 99.45 percent. LILETTA is indicated for women regardless of parity or Body Mass Index (BMI) and can be inserted on the same day she visits the clinic, providing that she is not pregnant. During the ACCESS IUS clinical trial, the success rate for insertions with the new single-handed inserter was 99.2%.
LILETTA is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to three years and is greater than 99% effective. LILETTA is not permanent, it can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception. LILETTA can be used in women regardless of whether or not they’ve birthed a child. Allergan initially launched LILETTA in partnership with Medicines360, a non-profit global pharmaceutical company whose mission is to provide access to medicines for women regardless of their socioeconomic status, insurance status, or geographic location. The new LILETTA single-handed inserter with an optimized package received approval in May 2016, and will succeed the two-handed inserter, which was approved by the U.S. FDA in February, 2015.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aaf0eb2a-f88a-4f26-a445-0fd30176c326