BRIEF—FDA approves first new estrogen in USA in over half century

The US Food and Drug Administration has approved the New Drug Application (NDA) for the novel combined oral contraceptive Nextstellis (3mg drospirenone (DRSP) and 14.2mg of estetrol (E4) tablets).

Australia-based Mayne Pharma anticipates the commercial launch of Nextstellis by the end of June 2021.

Developed by Belgian drugmaker Mithra Pharmaceuticals, Nextstellis (also trade named Estelle) is the first and only contraceptive pill containing estetrol, a native estrogen, now produced from a plant source.

Estetrol is the first new estrogen introduced in the USA in more than 50 years, the companies said.

Nearly 10 million American women use short-acting combination (estrogen and progestin) contraceptives.

The US market for combined hormonal contraceptives generated $3.6 billion in sales according to IQVIA for the 12-month period ending January 2021.

As a result of receiving FDA approval, Mayne Pharma will pay Mithra $11 million in cash and issue 85.8 million ordinary Mayne Pharma shares.