U.S.-based Adeza has submitted a new drug application (NDA) to the U.S. FDA for Gestiva, the company's drug candidate to prevent preterm birth in women with a history of preterm delivery. The drug is a long-acting, naturally occurring form of progesterone.
Adeza has requested priority review for the NDA that, if granted, would set a six-month goal for review by the FDA. The company has also submitted an application to the FDA requesting orphan-drug designation.
"OB/GYNs are beginning to use this form of progesterone in women with a history of prior preterm birth based on a 2003 American College of Obstetricians and Gynecologists recommendation that followed an NIH study, " said Durlin Hickok, vice-president of medical affairs at Adeza. "Preterm birth is a major health problem and Adeza is excited about the opportunity to help infants and families," he added.