The committee recommended by a majority vote that the data presented by Adeza in its new drug application for Gestiva support efficacy in preventing preterm birth prior to 35 weeks and that overall safety data is adequate and sufficiently reassuring to support marketing approval in women with a history of preterm delivery.
Although advisory committee recommendations are not binding, typically FDA final determinations are consistent with their recommendations. The FDA is expected to complete its review or otherwise respond to the Gestiva NDA by October 20, 2006.
“We are pleased by the Advisory Committee’s support for this important therapeutic for the prevention of preterm birth in women with a history of preterm delivery,” said Emory Anderson, president and CEO. “With approximately one preterm birth every minute and a $26 billion annual cost to the US health care system, preterm birth is a major public health issue.”
Gestiva is a long-acting form of a naturally occurring progesterone. The use of this form of progesterone is recommended by the American College of Obstetricians and Gynecologists (ACOG) in the treatment of women for recurrent preterm birth. If Gestiva receives FDA approval, Adeza will have the only commercially available, National Institutes of Health-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth.