First E4-based product approved internationally
- Canadian regulatory approval is the first in the world for the novel combined oral contraceptive Estelle®
- Innovative product developed by Mithra containing the unique native estrogen Estetrol (E4) and drospirenone (DRSP)
- Approval supported by two large multinational Phase 3 studies conducted in 3,725 women
- Commercial launch in Canada anticipated mid-summer 2021
LIEGE (Belgium – 7:30AM CET) and MONTREAL (Canada – 7:00AM EST), March 8, 2021 – Mithra and Searchlight Pharma announce today that Health Canada has approved Estelle® under the trademark Nextstellis®, the first and only combined oral contraceptive (COC) product based on the unique native estrogen Estetrol (E4). Once launched, E4 will be the first new estrogen in a COC in the Canadian market in over half a century, and will be the only COC alternative to ethinyl estradiol-based COC pills in Canada.