An FDA "approvable" letter for Adeza's Gestiva requests an additional animal study and "certain other conditions" before approval can be granted for the preterm birth agent, the company reported Oct. 23. The firm is seeking approval of the long-acting form of progesterone for prevention of preterm birth in women with a history of preterm delivery.

The approvable letter also outlines post-approval clinical requirements consistent with recommendations made by FDA's Reproductive Health Drugs Advisory Committee in August, the Sunnyvale, Calif.-based company said.

The panel recommended approval of Gestiva based on the totality of the data, but was concerned that the primary endpoint in the pivotal study, preterm birth prior to 37 weeks, was not adequate. The panel also had several safety concerns, and suggested the collection of additional data to better characterize the relationship between Gestiva and still births and miscarriages (¹ Also see "Gestiva Passes Cmte. Review, But Further Study Of Miscarriage Risk Requested" - Pink Sheet, 28 August, 2006.).

In addition, the committee urged the collection of long-term safety data associated with its use, including a potential registry tracking children exposed to the drug during pregnancy through adolescence.

If approved, Adeza would be the first drug approved for the treatment of preterm birth. The company submitted the NDA for 17 alpha-hydroxyprogesterone caproate in May under the 505(b)(2) regulatory pathway, which was deemed applicable to the drug given the significant amount of data available on it.

The form of progesterone is already recommended by the American College of Obstetricians & Gyneclologists for the treatment of women with recurrent preterm birth. The submission was based on a National Institute of Child Health & Human Development double-blind, placebo-controlled study of 463 women with a history of preterm birth.

Adeza is seeking three-year exclusivity for the drug under Hatch-Waxman, but said FDA is expected to make a decision on exclusivity at the time of a potential final approval. The company has also submitted additional information to the agency in an attempt to gain orphan drug status for Gestiva, which would give it seven-year exclusivity. FDA already rejected an initial request for Orphan Drug status.

Columbia Laboratories, the makers of a Prochieve 8% progesterone gel, currently in development for the treatment of preterm birth and on the market as a progesterone supplement for infertile women during the first trimester of pregnancy, said the approvable letter for Gestiva shows that a single clinical study "can be sufficient for approval if the study shows a meaningful effect on mortality, irreversible morbidity or prevents a medical condition with a potentially serious outcome."

The Livingston, N.J.-based company said it is on track to submit an sNDA for Prochieve in mid-2007 for an indication for the treatment of preterm birth. Columbia is studying Prochieve in a clinical trial based on a primary endpoint of reduction of preterm birth at 32 weeks, a timeframe the FDA advisory committee suggested was optimal for fetal and neonatal morbidity and mortality data (² Also see "Columbia’s Prochieve Could Get Competitive Edge From Committee Review Of Rival Product" - Pink Sheet, 30 August, 2006.).

- Jessica Merrill (j.merrill@elsevier.com)

FDA “Approvable” Letter For Gestiva Recommends Additional Animal Study

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