Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years.
The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a news release.
Liletta is designed to be placed in a woman’s uterus to prevent pregnancy for up to six years and should be replaced after six years if the user desires continued use. Liletta won FDA approval in February 2015, then picked up approval for four-year duration in August 2017 and got the nod for five-year duration in October 2018.
Medicines360 said the application won approval after a review of additional efficacy and safety data from its ongoing Access IUS Phase III U.S. clinical trial. The company said Liletta proved to be more than 99% effective in preventing pregnancy for up to six years in a diverse group of 1,751 women with varying age, race and body mass index.
“Our mission has always been to meet the diverse and unique health needs of all women, and this approval of Liletta for up to six years means women have even greater flexibility and choice when it comes to their reproductive health,” Medicines360 CEO Dr. Jessica Grossman said in prepared remarks. “Studying our products in robust clinical trials, like Access IUS, ensures we can provide quality birth control that works for a broad range of women in the U.S., something we take pride in for leading the way.”
“I hear all the time from women that they want a reliable and long-term option for birth control that is reversible,” added Columbia University’s Dr. Carolyn Westhoff. “This groundbreaking trial has given healthcare providers the ability to confidently offer women the option of pregnancy prevention for up to six years.”
“Our partnership with Medicines360 helps to ensure that women can obtain an effective, long-term birth control option,” said Allergan EVP & chief research & development officer David Nicholson. “Our goal is to provide a variety of contraceptive options for women so they and their healthcare providers can choose what is best for them. We are proud to deliver a product that now provides women with an even longer duration of pregnancy prevention.”
Shares of AGN were up 0.3% at $174.34 per share in midday trading today.