A Framingham biotech firm is moving to expand the use of its blood clot treatment to become the first drug specifically for the pregnancy disorder preeclampsia.
REVO Biologics Inc. yesterday asked the U.S. Food and Drug Administration for approval to test its therapy, ATryn, in women with preeclampsia who are 24 to 28 weeks pregnant. The drug was approved in 2009 to treat serious blood clots in pregnant women.
REVO, a subsidiary of the European company LFB Group, believes the drug can prolong pregnancy in women with early preterm preeclampsia and postpone when they deliver their babies.
"There is currently no treatment for preeclampsia," said Tom Langford, a spokesman for rEVO. "The only thing doctors can do is to deliver the baby — which often results in severely premature births. The alternate is to try to keep the baby in vitro for as long as possible. But each day of waiting increases the danger to the mom's life."
Preeclampsia is a sudden spike in blood pressure that can be life-threatening. It affects 5 percent to 8 percent of all pregnancies, according to the Preeclampsia Foundation.
The condition is more common in developing countries than in the United States, but rEVO's target market for its drug is domestic, Langford said.
The FDA has 30 days to respond to rEVO's request. The company is seeking 120 women for its trial, which will continue throughout 2015.
The drug, which is derived from the milk of genetically engineered goats, will be given intravenously.
Anda sedang membaca artikel tentang
Biotech co. pushes FDA to OK drug for pregnancy disorder
Dengan url
http://sedangapasaja.blogspot.com/2014/02/biotech-co-pushes-fda-to-ok-drug-for.html
Anda boleh menyebar luaskannya atau mengcopy paste-nya
Biotech co. pushes FDA to OK drug for pregnancy disorder
namun jangan lupa untuk meletakkan link
Biotech co. pushes FDA to OK drug for pregnancy disorder
sebagai sumbernya
0 komentar:
Posting Komentar