FDA Approves Drug for Prevention of Pre-Term Birth

The U.S. Food and Drug Administration (FDA) has approved the first drug to aid in the prevention of premature birth. It is anticipated the use of the drug, known as Makena (hydroxyprogesterone caproate), will reduce the risk of premature delivery that puts newborns at a greater risk of experiencing complications at birth, suffering from permanent disabilities, and having a decreased chance for survival.

The approval of the drug is for use in women who have experienced a prior spontaneous preterm delivery occurring within 37 weeks of pregnancy. Recurrence is known to be the most common risk factor for preterm birth. In addition, FDA spokeswoman Shelly Burgess pointed out that Makena is only approved for use in those women at risk for preterm birth who are carrying a single fetus and who previously gave birth prematurely to a single baby. The drug is not intended for use in women who are carrying multiple fetuses, or who have other risk factors for preterm birth.

Burgess stated that the drug was approved through the FDA accelerated approval process “which allows for promising drugs to be approved based on showing a benefit on a ‘surrogate endpoint’ that is likely to predict an actual clinical benefit.”

The approval of Makena was based on a randomized, double-blind clinical trial of 463 women ranging in age from 16 to 43 years, who were pregnant with a single fetus and had a history of spontaneous preterm birth. Among the participants who received the drug, 37 percent delivered prior to 37 weeks of pregnancy, in comparison to 55 percent women in the control group.

In a second study that assessed the development of the children born to the women in the initial trial, findings showed that children between the ages of 2.5 to 5 years from both groups achieved similar development targets. A third study is in progress to confirm the findings of the first two, and is expected to enroll between 580 and 750 infants. The FDA plans to follow this confirmatory study by an infant follow-up study similar to the one already done and expects its completion to occur by 2018.

Makena is administered by a once weekly injection into the hip, beginning at 16 weeks, and no later than 21 weeks of pregnancy, and ending with the 37th week. Side effects include pain, swelling, and itching at injection site, hives, nausea, and diarrhea. A single case of Pulmonary embolism, as well as one report of injection site infection occurred during the initial trial.

The drug was originally approved in 1956 under the name Delalutin for the treatment of hormone disturbances and cancer. However, the manufacturer withdrew the drug from the market in 2000 for business reasons. Makena is being marketed by St. Louis-based KV Pharmaceutical.

According to the March of Dimes, preterm birth at less than 37 completed weeks of pregnancy affects one in eight babies born in the U.S. Burgess pointed out that the rate of preterm birth has increased in excess of 35 percent in the last 25 years, with those occurring at 34 to 36 weeks of pregnancy accounting for nearly three-quarters of them.

Although not all risk factors can be avoided during pregnancy, planning for a healthy pregnancy is a good start. Proper nutrition and a healthy amount of exercise can benefit you as well as your unborn child.

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By Drucilla Dyess