BRIEF—Novel birth control pill launches in USA

Australia’s Mayne Pharma and Belgium-based Mithra Pharmaceuticals have announced the US commercial launch of the first novel estrogen-based contraceptive in fifty years.

Nexstellis (drospirenone/estetrol) was approved by the Food and Drug Administration in April 2021 and is the first and only pill containing E4, a natural estrogen that is synthesised from a plant source.

With market access efforts underway, the firm hopes to build up a presence in the market for short-acting combination hormonal contraceptives, which is valued at $3.5 billion.

Developed by Mithra, Mayne has an exclusive 20-year license and supply deal for Nexstellis in the USA and Australia, where approval is pending.

Mayne chief executive Scott Richards said: “Our key priorities with this launch are to educate the market on the benefits of Nexstellis and the new estrogen E4, gain broad payor acceptance and reimbursement, and ultimately become the preferred branded oral contraceptive in the market.”