Adeza has submitted a New Drug Application (NDA) with the US FDA for Gestiva, the company's drug candidate to prevent preterm birth in women with a history of preterm delivery.
Adeza has requested Priority Review for the Gestiva NDA that, if granted, would set a six-month goal for review by the FDA. Adeza has also submitted an application to the FDA requesting Orphan Drug designation. Gestiva is a long-acting, naturally occurring form of progesterone. If Gestiva is approved, Adeza will have the only commercially available, NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth, stated a release.
"Gestiva represents an ideal strategic fit for Adeza and is consistent with our mission to market and sell a broad array of high-value innovative products addressing women's healthcare," Emory V. Anderson, president and chief executive officer said adding, "If Gestiva is approved, the Adeza 87-person sales force will market Gestiva to the same physicians to whom we market FullTerm, The Fetal Fibronectin Test, thereby leveraging our direct sales efforts."
"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 Gynaecologists (ACOG) recommendation that followed an NIH study published in the June 2003 New England Journal of Medicine. Currently, this form of progesterone is prepared solely by compounding pharmacies. Subject to approval, Gestiva will be widely available and manufactured under strict FDA requirements," said Durlin E. Hickok, vice-president, medical affairs. "Preterm birth is a major health problem and Adeza is excited about the opportunity to help infants and families," he added.
Preterm birth is defined as delivery before 37 completed weeks of gestation. According to the New England Journal of Medicine, preterm births have historically accounted for up to 85% of all pregnancy-related complications and deaths in the United States. The March of Dimes estimates that more than $18.1 billion in costs were associated with the care of preterm or low-birth-weight infants in 2003. Women with a history of preterm birth represent one of the highest risk groups for a future preterm delivery. Adeza believes that treating women in this group with Gestiva has the potential to significantly reduce preterm birth costs.