WASHINGTON -- The FDA has approved a hydroxyprogesterone caproate (Makena) injection to reduce risk of preterm delivery before 37 weeks of pregnancy for women with at least one spontaneous preterm birth.
The drug's approval was based on a 463-patient, randomized, double-blind clinical trial of women 16 to 43 years old, pregnant with a single fetus, and with a history of spontaneous preterm birth.
Of those in the hydroxyprogesterone group, 37% delivered before 37 weeks versus 55% in the control group.
A second study evaluated the development of the children born in the trial, which found that children ages 2.5 to 5 years from both control and drug groups reached similar development targets.
The drug was approved through the FDA's accelerated approval program, which approves a drug based on a surrogate endpoint benefit that is likely to predict clinical outcome.
A third study confirming results of the first two studies and expected to enroll 580 to 750 infants is currently ongoing, an FDA statement said.
The drug is designed to be given once a week by injection into the hip, beginning at 16 weeks and no later than 21 weeks of pregnancy, according to the agency.
Adverse events include pain, swelling, and itching at injection site, hives, nausea, and diarrhea. There was one report of pulmonary embolism and one of injection site infection during the trial.
The drug was originally approved in 1956 under the name Delalutin to prevent threatened miscarriage. The manufacturer requested the drug withdrawn from the market in 2000 for reasons unrelated to safety.
Makena is manufactured by Baxter Pharmaceutical Solutions, based in Bloomington, Ind.