Medicines360, a San Francisco-based nonprofit organization, has achieved a significant milestone with the recent FDA approval of its supplemental New Drug Application (sNDA) for LILETTA. This approval allows LILETTA (levonorgestrel-releasing intrauterine system) 52 mg to be utilized as a treatment option for Heavy Menstrual Bleeding (HMB) for up to five years in women who opt for intrauterine contraception.
Extensive research has demonstrated the efficacy of the levonorgestrel 52 mg intrauterine system (IUS) in reducing bleeding for patients with HMB. “For those experiencing HMB, medical treatments are preferred over surgical treatment as they are more convenient and pose less risk,” said Andrea Olariu, M.D., PhD, and CEO of Medicines360. “With limited choices of hormonal IUDs to treat HMB, we are pleased to deliver on our mission by working to offer prescribers and patients another medical treatment option.”
The FDA’s approval was based on comprehensive data from a Phase 3 clinical trial conducted by Medicines360, which included participants of diverse demographics, including age, race, parity, and body mass index (BMI). The results of this trial were published in Obstetrics and Gynecology in May 2023.
LILETTA is commercially available in the United States through Medicines360’s nonprofit pharmaceutical model. Additionally, public health clinics enrolled in the 340B Drug Pricing Program can access LILETTA at a reduced cost, improving its affordability and accessibility.