An FDA expert advisory panel is recommending approval of Adeza BioMedical's Gestiva to prevent preterm birth, saying that it shouldn't be forced to mount a new trial before the therapy hits the market. The vote was 13 to 8. The committee on reproductive health drugs, though, did recommend that the FDA require a post-marketing study. Gestiva is a long-acting form of a naturally occurring progesterone and, if finally OK'd by the FDA, would be the first approved therapy to hit the market to prevent preterm labor. Gestiva is being given a priority review by the agency.
"With approximately one preterm birth every minute and a $26 billion annual cost to the U.S. healthcare system, preterm birth is a major public health issue," said Emory V. Anderson, president and chief executive officer of the Sunnyvale, CA-based drug developer. "Treating women with a history of preterm birth with Gestiva could considerably reduce preterm birth and the associated costs for this high risk group."
- check out the HealthDay News report on Adeza