FDA advisers back 5-day "morning after" pill

Maryland - A new, longer-lasting emergency contraceptive pill moved closer to the U.S. market on Thursday after U.S. medical advisers unanimously backed the one-dose drug as a safe and effective option to prevent an unplanned pregnancy.


Data for the drug, made by the French drugmaker HRA Pharma but to be sold by Watson Pharmaceuticals Inc in the United States, was compelling, the U.S. Food and Drug Administration's advisory panel said.


A type of so-called "morning after" pill, the companies hope to market the prescription drug to teenagers and adult women under the brand name ella, saying their product works two days longer than the currently-available option.


Representatives for HRA Pharma told the FDA panel having a more effective emergency contraceptive is key, especially for women whose routine birth control fails or who have been sexually assaulted.


"Every woman deserves a last chance to prevent pregnancy," said James Trussell, director of office of population research at Princeton University.


The current emergency contraceptive option in the United States, Teva Pharmaceutical Industries Ltd's Plan B, is approved for use up to three days after intercourse. Ella aims to prevent ovulation for as long as five days after unprotected sex.


Unlike Plan B, which is available for women aged 17 and older without a prescription, ella would require a doctor's note if cleared for the U.S. market. The FDA will weigh its panel's recommendation as it makes its approval decision.


Ella is a type of selective progesterone receptor modulator, a class of drugs that includes the abortion pill known as RU-486, or mifepristone, and sold as Danco Laboratories' Mifeprex. Such drugs interfere with the hormone progesterone, which is critical for pregnancy.


Ella, known chemically as ulipristal, was approved last year in Europe under the brand name ellaOne and is used in 22 countries, the drugmaker said.


A spokeswoman for HRA Pharma said the FDA's decision is expected by October.


(To read full article, visit this Reuters link.)

Filed under