Research & Development
Mithra Pharmaceuticals postpones DONESTA NDA filing to allow for additional analyses
30 November 2023 -

Belgian biopharmaceutical company Mithra Pharmaceuticals SA (Euronext Brussels:MITRA) reported on Thursday that it has received feedback from the US Food and Drug Administration (FDA) regarding its marketing authorisation filing for DONESTA, an oestrogen-based therapy for vasomotor symptoms of menopause.

This follows an earlier agreement in principle with the FDA to conduct additional endometrial data analyses in order to address variations in endometrial biopsy diagnoses and optimise market potential. The formal New Drug Application (NDA) submission is now planned for Q4 2024 to allow for the time required to perform these additional analyses pursuant to FDA guidance.

Due to the delay, complementary data will be submitted for both the FDA and the European Medicines Agency (EMA) within the same time frame.

Welcoming the FDA's feedback, Mithra's chief scientific officer Graham Dixon said: "Estetrol's action on the uterine lining is well understood and expected. These additional data inform our research on other promising applications of E4 in women's health.

"In fact, this effect can potentially be used as a treatment to enhance fertility for women who are undergoing IVF, for example. We have begun research to explore an estetrol-based solution for this market."

Mithra added that it continues to actively seek a commercialisation partner for the US market and has received positive interest from several potential candidates.