Mithra, a company dedicated to Women’s Health, today announces the New Drug Application (NDA) for Estelle® has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.
Developed by Mithra, the product candidate is composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is produced by the human foetal liver during pregnancy. Following many years of research and development, Mithra can synthesise E4 at scale through a complex plant-based production process.
The NDA submission includes results from two phase III clinical studies conducted on 3,725 women. Estelle® showed positive top-line results against primary efficacy and safety endpoints and achieved positive secondary endpoints including good bleeding profile, cycle control, and tolerability.
If approved, Estelle® would be the first contraceptive product containing E4 and the first new estrogen introduced in the US for contraceptive use in approximately 50 years. US sales of combined hormonal contraceptives are more than US$ 4 billion per annum, with 10 million US women using combination (estrogen + progestin) oral pills, patches or vaginal rings . Mithra recently extended its strategic relationship with Mayne Pharma to also commercialize Estelle® in the Australian market .
Mayne Pharma’s CEO Scott Richards said, “This is another important milestone for E4/DRSP and brings us one step closer to providing women in the US with a new contraceptive that we believe will be effective, safe and well-tolerated. We look forward to working with the FDA and Mithra during the ongoing review of our application. In parallel, we continue to advance our US commercial strategy and infrastructure to ensure we are well positioned to support the potential launch of E4/DRSP in the first half of calendar 2021.”
François Fornieri, CEO Mithra Women’s Health, commented :“We are very pleased to have received filing acceptance in the US, the world’s largest pharmaceutical market. We continue to believe that our product has the potential to revolutionize the contraceptive landscape, offering an optimal benefit/ risk profile to women around the world and where predicted environmental exposure to Estetrol due to human use is unlikely to have negative effects on aquatic environments.”