UPDATE US FDA advisers back 5-day "morning after" pill
GAITHERSBURG, Md. (Reuters) - A new, longer-lasting emergency contraceptive pill moved closer to the U.S. market 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 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.
Although emergency contraception has been marketed to U.S. women for more than a decade, such pills continue to spark debate with conservatives blasting their interference with pregnancy and women's health advocates urging additional family planning options.
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.
Emergency contraceptive drugs, while potential political hot buttons, are not necessarily major money-makers.
Teva's two-pill Plan B and one-pill Plan B One-Step took in roughly $125 million in 2009, according to IMS Health, which tracks prescriptions and sales. Plan B saw 257,000 prescriptions last year, according to the health data firm.
Watson saw nearly $22 million in 2009 from its generic version of Plan B, called Next Choice, IMS Health data showed.
POLICE BUT NO SPARKS
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.
But while Mifeprex is given in conjunction with another drug to terminate a pregnancy once it begins, HRA Pharma and the FDA said ella appears to work primarily by preventing the release of a woman's egg for up to five days after unprotected sex, although the lining of the uterus is also affected.
Anti-abortion groups, who also fought against Plan B, cautioned FDA's panel against supporting the drug and questioned whether there were abortion properties to the drug. They also cited safety concerns, the potential for increased unprotected sex and misuse.
Such drugs "are just as easily used by men to exploit women," said Concerned Women for America President Wendy Wright.
But David Archer, an Eastern Virginia Medical School professor and consultant for HRA Pharma, said he did not "see any evidence at all ... that would allow me to say this has an abortifacient activity."
At the same time, abortion rights groups and women's health advocates urged the FDA to look solely at the data and avoid the political delays that kept Plan B from going over-the-counter for more than five years under President George W. Bush's administration.
Despite the potential political clashes, the meeting -- which spurred a cautionary presence by local police -- saw few sparks and much of the meeting room was empty.
Overall, FDA's advisers said the data clearly showed ella worked with no significant safety issues. The most commonly reported side effects were nausea, headache and abdominal pain, according to the company and the FDA.
"The efficacy data was very convincing," said panelist Kathleen Hoeger, a University of Rochester Medical Center obstetrician and gynecologist, echoing other panel members. The panel did acknowledge that ella's effect on pregnancy and fetuses was unclear, a fact they said should be mentioned on the drug's label and further studied.
One potential pitfall is that ella was somewhat less effective in obese women, a potential concern in the United States where two out of three Americans are overweight or obese.
The drug also did not work in women who had unprotected sex again after taking the drug. That prompted concern that some women may think ella protects them for five days against pregnancy when in fact sperm from additional intercourse could outlive the initial five-day window, something HRA Pharma officials said would warrant patient education.
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.
source
So far so good. :)
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 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.
Although emergency contraception has been marketed to U.S. women for more than a decade, such pills continue to spark debate with conservatives blasting their interference with pregnancy and women's health advocates urging additional family planning options.
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.
Emergency contraceptive drugs, while potential political hot buttons, are not necessarily major money-makers.
Teva's two-pill Plan B and one-pill Plan B One-Step took in roughly $125 million in 2009, according to IMS Health, which tracks prescriptions and sales. Plan B saw 257,000 prescriptions last year, according to the health data firm.
Watson saw nearly $22 million in 2009 from its generic version of Plan B, called Next Choice, IMS Health data showed.
POLICE BUT NO SPARKS
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.
But while Mifeprex is given in conjunction with another drug to terminate a pregnancy once it begins, HRA Pharma and the FDA said ella appears to work primarily by preventing the release of a woman's egg for up to five days after unprotected sex, although the lining of the uterus is also affected.
Anti-abortion groups, who also fought against Plan B, cautioned FDA's panel against supporting the drug and questioned whether there were abortion properties to the drug. They also cited safety concerns, the potential for increased unprotected sex and misuse.
Such drugs "are just as easily used by men to exploit women," said Concerned Women for America President Wendy Wright.
But David Archer, an Eastern Virginia Medical School professor and consultant for HRA Pharma, said he did not "see any evidence at all ... that would allow me to say this has an abortifacient activity."
At the same time, abortion rights groups and women's health advocates urged the FDA to look solely at the data and avoid the political delays that kept Plan B from going over-the-counter for more than five years under President George W. Bush's administration.
Despite the potential political clashes, the meeting -- which spurred a cautionary presence by local police -- saw few sparks and much of the meeting room was empty.
Overall, FDA's advisers said the data clearly showed ella worked with no significant safety issues. The most commonly reported side effects were nausea, headache and abdominal pain, according to the company and the FDA.
"The efficacy data was very convincing," said panelist Kathleen Hoeger, a University of Rochester Medical Center obstetrician and gynecologist, echoing other panel members. The panel did acknowledge that ella's effect on pregnancy and fetuses was unclear, a fact they said should be mentioned on the drug's label and further studied.
One potential pitfall is that ella was somewhat less effective in obese women, a potential concern in the United States where two out of three Americans are overweight or obese.
The drug also did not work in women who had unprotected sex again after taking the drug. That prompted concern that some women may think ella protects them for five days against pregnancy when in fact sperm from additional intercourse could outlive the initial five-day window, something HRA Pharma officials said would warrant patient education.
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.
source
So far so good. :)