FDA approval of 17P
The first-ever drug known to prevent some preterm births won market approval today from the Food and Drug Administration.
“For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life,” said Alan Fleischman, MD, senior vice president and medical director of the March of Dimes. “Women who already have had a baby born prematurely should check with their health care provider to see if this treatment is appropriate for them. This treatment is not for everyone.”
The FDA approved hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy. It will be marketed under the brand name Makena™ and given in weekly injections to pregnant women between 16 and 20 weeks gestation and continuing until 37 weeks gestation. The drug is approved for use by women pregnant with one baby and who already have a baby who was born before 37 weeks of pregnancy either because labor began on its own, without drugs or other methods, or because the membranes surrounding the baby ruptured too early.
Prior to today’s approval of Makena™, health care providers ordered prescriptions of 17P from compounding pharmacies; however, many eligible patients faced logistical and financial barriers to access. FDA approval means the drug now will be widely available only in specialty pharmacies and that there will be improved access of the drug through healthcare coverage.
A published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, using data from 2002, estimated that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.