The US Food and Drug Administration (FDA) has approved the Makena (hydroxyprogesterone caproate) injection, which can reduce the risk of preterm delivery.
The drug is intended for use in pregnant women with a history of at least one spontaneous preterm birth.
It is not intended for women with multiple pregnancy or other risk factors for preterm births.
The FDA reviewed data on the safety and effectiveness of Makena in a multi-centre, randomised and double-blind clinical trial.
The study included 463 women aged 16-43 who were pregnant with a single foetus and had a history of a prior spontaneous preterm birth.
Among women treated with Makena, 37% delivered early (before 37 weeks) compared with 55% of women in the control group.
The FDA approved Makena under the agency's accelerated approval regulations.
Under these regulations, the manufacturer must conduct additional studies following approval to demonstrate that the drug has clinical benefit.
Sandra Kweder, deputy director of the FDA Center for Drug Evaluation and Research, Office of New Drugs, said that preterm birth is a significant public health issue in the US.
"This is the first drug approved by the FDA that is indicated to specifically reduce this risk," Kweder added.
SOURCE:pharmaceutical-technology
