Progesterone for Preterm Birth
In April 2011, Columbia submitted an NDA for PROCHIEVE® (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. This NDA included data from the PREGNANT study, a Phase III clinical study in which administration of PROCHIEVE was associated with a 44% reduction in the incidence of preterm birth before 33 weeks gestation. This reduction achieved statistical significance (p=0.022) for the primary endpoint of this study. The Advisory Committee for Reproductive Health Drugs of the FDA reviewed this NDA on January 20, 2012. While panel members generally agreed that progesterone vaginal gel 8% is safe, the Committee stated that more information is needed to support approval. Though the FDA will consider recommendations of the Committee, the final decision regarding the approval of the product rests solely with the FDA. The FDA is expected to take action on the NDA by February 26, 2012.
