MakenaTreatment for Premature Labor
Update: Makena (hydroxyprogesterone caproate) Now FDA Approved - February 3, 2011
Adeza Submits New Drug Application For Gestiva to Prevent Preterm Births
SUNNYVALE, Calif., May 4, 2006--Adeza today announced the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (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.
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.
"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," said Emory V. Anderson, president and chief executive officer. "If Gestiva is approved, the Adeza 87-person sales force will market Gestiva to the same physicians to whom we market FullTerm(TM), 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 Gynecologists (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, MD, vice-president, medical affairs. "Preterm birth is a major health problem and Adeza is excited about the opportunity to help infants and families."
Background to Gestiva
Adeza's NDA submission for Gestiva includes data from a clinical study conducted by the National Institute of Child Health and Human Development, one of the institutes of the NIH. The NIH studied a long-acting form of a naturally occurring progesterone, 17 alpha-hydroxyprogesterone caproate (17P), in a multi-center, double-blind, placebo-controlled trial that enrolled 463 women with a prior history of preterm birth. Patients were enrolled at 16 to 21 weeks of gestation and randomly assigned to receive weekly injections of 17P or placebo. Treatment continued until delivery or 37 weeks of gestation, resulting in a reduction in the preterm birth rate of 34% among women treated with 17P. In addition, infants born to women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of respiratory therapy.
Posted: May 2006
- FDA Approves Makena to Reduce Risk of Preterm Birth in At-Risk Pregnant Women - February 4, 2011
- K-V Pharmaceutical Company Updates Status of New Drug Application for Gestiva - January 12, 2011
- KV Pharmaceutical's Launch of Gestiva Delayed - January 26, 2009
- KV Provides Update on Gestiva PDUFA Date - October 21, 2008
- Hologic Announces Sale of Gestiva - January 22, 2008
- Adeza Receives FDA Approvable Letter for Gestiva - October 23, 2006
- FDA Advisory Committee Recommends Approval of Adeza’s NDA for Gestiva to Prevent Preterm Birth - August 29, 2006
- Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births - July 18, 2006
- FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births - July 6, 2006
- FDA Grants Adeza Priority Review for Gestiva to Prevent Preterm Births - June 5, 2006