March of Dimes urges FDA to approve Gestiva

Aug 30 2006

The March of Dimes has urged Food and Drug Administration officials to promptly approve a commercial progesterone therapy that appears to prevent some premature births.

Dr. Nancy Green, March of Dimes medical director, testified before the FDA Advisory Committee for Reproductive Health Drugs, which met to discuss "Gestiva," also known as 17 alpha-hydroxyprogesterone or 17-P.

"Studies of progesterone injections offer promise that the risk of recurrent preterm births will be reduced in a select group of women who already had a baby born too soon," said Dr. Green. "We hope the FDA will approve the licensing of this drug so those women can be helped by this treatment."

Nationwide, nearly a half million babies are born too soon each year and babies who survive face risks of lifelong developmental challenges, such as cerebral palsy, mental retardation, chronic lung disease, and vision and hearing loss. The Institute of Medicine estimates the national cost of premature birth in 2005 exceeded $26 billion.

Progesterone is given as weekly injections during the second half of pregnancy. FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid.

Obstetricians who treat women with a high risk pregnancy, such as those with a history of spontaneous preterm birth, often offer progesterone treatments. A 2005 survey found 67 percent of these obstetricians use progesterone compared to 38 percent in 2003.

A large study found that for women who had a previous premature baby 17-P reduced the preterm birth rate by 33 percent compared to a control group. The March of Dimes estimated that if all women eligible for the progesterone therapy had received it, nearly 10,000 premature births might have been prevented in 2003.

While there is no evidence that 17-P has an adverse effect on infants, the March of Dimes remains cautious about its use and is concerned that women without a previous premature baby are receiving the injections.

Dr. Green asked the FDA to monitor the drug for possible adverse effects on infants. She also recommended the FDA direct that, given what is known about its efficacy, Gestiva should only be used by women with a history of spontaneous premature birth.