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March of Dimes welcomes FDA approval of progesterone injections

WHITE PLAINS, NY, Feb. 4, 2011 The first-ever drug known to prevent some preterm births, which won market approval today from the Food and Drug Administration, was welcomed by the March of Dimes.

"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.

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.

Nikki and Densel Fleming's first child, Lauren, was born 3 months early, weighing only two pounds, one ounce. Lauren was hospitalized for five months, a scary and agonizing time for the Marvin, N.C. couple. Although they wanted a bigger family, the Flemings knew Lauren's early birth increased the chance that future babies also would be born too soon. Nikki received weekly progesterone injections for her next two pregnancies and their next two children, Erin and Corbin, were born nearly full term.

"I thank the March of Dimes for making high-risk pregnant women aware of progesterone treatments because, in my heart, I know that the weekly injections I received while pregnant, combined with the knowledge doctors now have about the causes and signs of preterm labor, helped Erin and Corbin be born full term," said Nikki Fleming.

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

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