US FDA approves ella®
16th August 2010
On 13 August, HRA Pharma announced that the US Food and Drug Administration (FDA) granted approval for ella® (ulipristal acetate) as a prescription-only emergency contraceptive indicated for use within 120 hours (five days) of unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive. ella was approved by 22 countries in Europe last fall, and will be distributed in the US by Watson Pharmaceuticals, which also distributes a generic levonorgestrel-alone EC product “Next Choice”.
The approval is based on two Phase 3 studies that showed that ella significantly reduced the risk of pregnancy in women who used it after unprotected intercourse. A progesterone agonist/antagonist that potently inhibits follicular rupture when taken just before ovulation is to occur, ella has been shown to be consistently effective when used up to five days after intercourse. Currently-marketed emergency contraceptives based on levonorgestrel are labeled for use within 72 hours or three days of intercourse.
The International Consortium for Emergency Contraception will update their Medical and Service Delivery Guidelines to include ulipristal acetate by the end of 2010.