FDA Medical Advisors Support EllaOne

A new emergency contraceptive, ellaOne, is a step closer to approval in the United States. The Food and Drug Administration (FDA) medical advisors unanimously agreed that it is safe and effective in preventing pregnancy for five days after unprotected sex by preventing the release of an egg. It is planned to be marketed under the name “ella” in the United States and would require a prescription. One panelist, Dr. Kathleen Hoeger, told Reuters “The efficacy data was very convincing.” Hoeger is a University of Rochester Medical Center obstetrician and gynecologist. EllaOne was approved in Europe last year and The FDA is expected to provide a final decision by October. Erin Gainer, chief executive of HRA Pharma of Paris, said to the Seattle Times, “There is a great unmet need out there for emergency contraception that is effective as this for so long.” According to USA Today , the pill has been proven in studies to be more effective than the current leading emergency contraceptive, levonrgestrel. Levonorgestrel, most notably sold under the brand name Plan B, must be taken within three days of sexual activity. When taking EllaOne, the window of effectiveness expands to five days. Medical News Today reports that ellaOne is shown to have more consistent efficacy compared to Plan B. USA Today reports that women who took ellaOne had a 1.8 percent chance of pregnancy compared 2.6 percent for those who took Plan B. EllaOne, made by French company HRA Pharma, is available with a prescription in Europe and is currently approved in 22 countries. If approved, Watson Pharmaceuticals Inc. would distribute it in the United States.


Reuters 6/17/10; The Seattle Times 6/11/10; USA Today 1/28/10; Medical News Today 5/28/10; Feminist Daily Newswire 6/16/10

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