Research & Development
US FDA accepts for review Mayne Pharma's E4/DRSP New Drug Application
25 June 2020 -

The United States Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) submitted by Australia-based Mayne Pharma Group Limited (ASX: MYX) for its E4/DRSP intended to prevent pregnancy, it was reported on Wednesday.

The US FDA is likely to complete its review in the first half of 2021.

The product has been developed by Mithra Pharmaceuticals SA and is a combined oral contraceptive pill containing 15mg estetrol and 3mg drospirenone. Mithra, a development and manufacturing partner of Mayne Pharma, can synthesise E4 at scale via a complex plant-based production process. The NDA includes results from two phase three clinical studies conducted in over 3,725 women aged 16 to 50 years.

If approved, E4/DRSP would be the first contraceptive product containing E4 and the first new estrogen introduced in the US for contraceptive use in approximately 50 years. Mayne Pharma recently extended its strategic relationship with Mithra to also bring E4/DRSP to the Australian market and plans to file the product with the Therapeutic Goods Administration (TGA) this calendar year.



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