Drug To Prevent Premature Birth can be pull off from the market

The FDA approved 17-hydroxyprogesterone caproate (Makena) in 2011 as a way to prevent preterm birth in women with a prior spontaneous preterm birth. The drug got the green light through the FDA’s accelerated approval pathway, which is reserved for drugs that treat a serious or life-threatening disease or condition. That certainly applies to preterm birth — birth before 37 weeks of pregnancy which is a major problem in the United States and around the world. 

Makena (hydroxyprogesterone caproate injection) is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. 

Now doctors fear that the only drug approved to prevent preterm birth will no longer be available to expectant mothers as the expert panel convened by the Food and Drug Administration recommended to withdraw approval and pull the drug off the market.

The FDA approved Makena based on a single clinical trial, the 2003 Meis study. It showed a reduction in preterm birth, but no direct clinical benefit, such as improvements in neonatal mortality and morbidity. As a condition of accelerated approval, the FDA required Makena’s maker, AMAG Pharmaceuticals, to conduct a second trial. The results of this second trial, known as PROLONG, were announced in March 2019: Makena did not work, meaning it did not prevent preterm birth.

Based largely on AMAG’s findings, the FDA’s expert panel recommended in October, in a 9-7 vote, that the FDA withdraw its approval of Makena. The seven dissenting members recommended keeping the drug on the market while conducting further study. So far, pending a final FDA decision, Makena is still on the market.