FDA clears Nextstellis from Mayne, Mithra

Mayne Pharma and Mithra have received the Food and Drug Administration’s approval for the novel combined oral contraceptive Nextstellis (3 mg drospirenone (DRSP) and 14.2 mg of estetrol (E4) tablets).

Developed by Mithra, Nextstellis is the first and only contraceptive pill containing estetrol, a native estrogen, which is produced from a plant source. Estetrol is the first new estrogen introduced in the United States in more than 50 years, the companies said.

Mayne Pharma’s CEO, Scott Richards said,“The approval of Nextstellis represents an important milestone, providing women with a new choice for their reproductive health. We are delighted to be introducing a new estrogen and bringing to market this novel, safe and effective option for women to consider with their healthcare providers.”

Combined hormonal contraceptives have a market value of $3.6 billion in sales for the 12 month period ended January 2021, according to IQVIA.

“We are very proud that our teams achieved this important milestone for the commercialization of Nextstellis in the world’s largest pharmaceutical market," Mithra’s CEO Leon Van Rompay said. "We look forward to working closely with our partner Mayne Pharma to make this commercial launch a success. The approval of Nextstellis represents a huge achievement for a biotech company such as Mithra and all the teams who made this ambitious project come to fruition. This is a critical step in Mithra’s journey to bring innovative medicines to the U.S. women’s health market. We believe the approval of Nextstellis represents a new era in contraception and demonstrates the potential of our E4 portfolio.”

Mayne anticipates the commercial launch of Nextstellis by the end of June.