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Home » ADVISORY COMMITTEE RECOMMENDS APPROVAL OF ADEZA'S GESTIVA
ADVISORY COMMITTEE RECOMMENDS APPROVAL OF ADEZA'S GESTIVA
The FDA's Health Drugs Advisory Committee has recommended by a majority vote that the data presented by Adeza in its new drug application (NDA) 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. The committee also recommended that the company collect postmarketing data.
Adeza submitted its NDA in May. In June the application was granted priority review status. If Gestiva receives FDA approval, it will be the only commercially available therapeutic for the prevention of recurrent preterm birth.
Adeza's submission includes data from a clinical study conducted by the National Institute of Child Health and Human Development, part of the NIH. The NIH studied a long-acting form of a naturally occurring progesterone, 17 alpha-hydroxyprogesterone caproate (17P), in a multicenter, 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 until delivery or 37 weeks of gestation. Treatment with 17P resulted in an overall reduction in the preterm birth rate of 34 percent and a reduction of 42 percent in the rate of preterm births prior to 32 weeks. In addition, infants born to women treated with 17P had significantly lower rates of serious complications.
KEYWORDS Drug Pipeline Alert
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