5-day-after Ella contraceptive pill wins FDA approval

Ella, the prescription-only emergency contraceptive, which faced much criticism from the anti-abortion groups, was approved Friday by the U.S. health watchdog to stay on the market.

FDA OKs Ella in U.S. market
Watson Pharmaceuticals, Inc., of Morristown, N.J. will begin preparations to commercialize the novel type of emergency contraception pill from French pharmaceutical company HRA Pharma of Paris in the fourth quarter this year, under an exclusive distribution agreement, according to several U.S. tabloid reports.

Developed in government laboratories, Ella will be dispensed as a single dose and women will need a prescription but could keep a supply at home. The pill prevents pregnancy from occurring when taken within 120 hours (5 days) of unprotected intercourse or contraceptive failure.

Ella, the prescription-only emergency contraceptive, which faced much criticism from the anti-abortion groups, was approved Friday by the U.S. health watchdog to stay on in the U.S. market.

Approved last year in Europe, Ella is now available in at least 22 countries under the brand name ellaOne. Formulated as a 30-mg tablet, the pill is a progesterone agonist/antagonist that inhibits or delays ovulation.

Panel agreed to Ella’s efficacy
In June this year, Ella was unanimously endorsed by the Reproductive Health Drugs Advisory Committee of the FDA, agreeing that the drug was safe and found no evidence it was capable of terminating an existing pregnancy.

Ella was proved effective and safe in two phase 3 clinical trials.

On Friday, the FDA granted approval for the marketing of the pill in the United States, where it will compete with Teva Pharmaceutical Industries Ltd.’s Plan B, the morning-after pill now available over the counter to women 17 and older.

Plan B vs Ella
The Plan B pill is only effective in the first 72 hours, while Ella can be taken within 120 hours, or five days, of unprotected intercourse or failure of some other contraceptive method, according to Washington Post.

The FDA said that women who are pregnant, or suspect that they are pregnant, and those who are breastfeeding should not use this product.

Maker, distributor happy with the nod
Ella’s “unique efficacy profile will give women an additional therapeutic alternative for preventing unintended pregnancy,” Fred Wilkinson, Watson’s executive vice president for global brands, said in a statement.

"As a pioneer and a leader in the field of emergency contraception, HRA Pharma is committed to providing women and their health care providers highly effective contraceptive options," said Erin Gainer, CEO of HRA Pharma. "ella, an effective and well-tolerated new generation emergency contraceptive, fulfills a significant and previously unmet need in this field by reducing pregnancy risk up to five days after intercourse."

About the contraceptive pills
Introduced in the 1960s, the oral contraceptives are medicines taken by mouth to help prevent pregnancy.

Commonly known as birth control pill, the medicine is now the world's most popular form of contraception used by more than 12 million women in the United States, some 3 million women in UK, and more than 60 million women worldwide, as per the estimates of U.S. Centers for Disease Control and Prevention.

The contraceptive pill that revolutionized birth control practices uses hormones to suppress ovulation. The pill, typically containing estrogen or progesterone, inhibits ovulation and thereby prevents conception.