Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer progesterone treatments to high-risk women.
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.
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.
In the United States, more than half a million babies are born preterm each year. Preterm birth, birth before 37 weeks of pregnancy, is a serious health problem that costs the United States more than $26 billion annually, according to the Institute of Medicine. It is the leading cause of newborn death, and babies who survive an early birth often face the risk of lifetime health challenges, such as breathing problems, cerebral palsy, intellectual disabilities and others. Even infants born just a few weeks early have higher rates of hospitalization and illness than full-term infants. The last few weeks of pregnancy are critical to a baby's health because many important organs, including the brain and lungs, are not completely developed until then.
|Contact: Elizabeth Lynch|
March of Dimes Foundation