Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years.
Liletta is a levonorgestrel-releasing intrauterine system that is placed in a woman’s uterus to prevent pregnancy for up to 3 years and is 99% effective, according to Dublin-based Allergan. The device is not permanent – a health care provider can take it out at any time, enabling the patient to choose between long-term or short-term contraception.
The FDA approved Liletta in February 2015 with a 2-handed inserter and in Januray 2016 it received additional approval for a single-handed inserter.
The supplemental application for the FDA included efficacy and safety data from an ongoing phase III hormonal intrauterine device trial, Allergan said in a statement. The U.S.-based trial has enrolled 1,751 women to evaluate the system. According to interim data, Lilietta is safe and effective for a broad range of women.
Allergan said last month that it will “vigorously defend” the patents for its Restasis eye drops, after the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board agreed to an inter partes review of 6 patents as requested by generic competitor Mylan (NSDQ:MYL). The patents are valid until August 2024.
A decision date was set for December 9th, 2017, as the board’s review process is expected to take 1 year.
