FDA Grants Adeza Priority Review for Gestiva to Prevent Preterm Births; Goal of 6 Months Set by FDA to Review NDA for Gestiva
05 6월 2006 - 7:00PM
Business Wire
Adeza (NASDAQ:ADZA) today announced that the U.S. Food and Drug
Administration (FDA) has granted the company's New Drug Application
(NDA) for Gestiva(TM) Priority Review status. A Priority Review
designation sets a six-month goal for review by the FDA. Priority
Review is granted to product candidates that, if approved, would
provide a significant improvement in the treatment, diagnosis or
prevention of a disease. Pursuant to Prescription Drug User Fee Act
(PDUFA) guidelines, the FDA has set a goal to complete its review
or otherwise respond to the Gestiva NDA by October 20, 2006.
Gestiva, a long-acting form of a naturally occurring progesterone,
is Adeza's drug candidate for prevention of preterm birth in women
with a history of preterm delivery. The March of Dimes estimates
that over $18 billion in costs were associated with preterm or
low-birth-weight infants in 2003. According to the New England
Journal of Medicine, preterm birth has historically accounted for
up to 85% of all pregnancy related complications and deaths in the
U.S. "A preterm birth occurs nearly every minute in the United
States, resulting in tremendous financial and human costs. Women
with a history of preterm birth are among the highest risk for
future preterm delivery," said Emory V. Anderson, president and
chief executive officer. "Treating women with previous preterm
birth with Gestiva has the potential to significantly reduce
preterm birth costs." In May 2006, Adeza announced the submission
of its NDA to the FDA under Section 505(b)(2) of the Federal Food,
Drug, and Cosmetic Act, which allows for FDA approval of new or
improved formulations of previously approved products. 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 until delivery or 37 weeks of
gestation. Treatment with 17P resulted in an overall reduction in
the preterm birth rate of 34% and a reduction of 42% in the rate of
preterm births prior to 32 weeks. 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. 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, NIH-studied,
ACOG-recommended and FDA-approved therapeutic for the prevention of
recurrent preterm birth. Adeza designs, manufactures and markets
innovative products for women's health. Adeza's initial focus is on
reproductive healthcare using its proprietary technologies to
predict preterm birth and assess infertility. Adeza's principal
product is a patented diagnostic test, FullTerm(TM), The Fetal
Fibronectin Test, which utilizes a single-use, disposable cassette
and is analyzed on Adeza's patented TLiIQ(R) System. This product
is approved by the FDA for use in assessing the risk of preterm
birth. Adeza also markets and sells the E-tegrity(R) Test, an
infertility-related test to assess receptivity of the uterus to
embryo implantation in women with unexplained infertility. In May
2006, Adeza announced the submission of an NDA with the FDA for
Gestiva, a long-acting form of a naturally occurring progesterone
to prevent preterm birth in women with a history of preterm
delivery. Adeza's NDA submission includes data from a clinical
study conducted by the National Institutes of Health. More
information is available at www.adeza.com. Adeza cautions you that
statements included in this press release that are not a
description of historical facts may be forward-looking statements,
including, for example, statements relating to Adeza's product
candidate Gestiva, and the timeline for review of regulatory
submissions related to Gestiva. The inclusion of forward-looking
statements should not be regarded as a representation by Adeza that
any of its plans will be achieved. Actual results may differ
materially from those set forth in this release due to the risks
and uncertainties inherent in Adeza's business, including, without
limitation, risks and uncertainties relating to the expansion of
products, markets and offerings, and additional product
indications, risks associated with the regulatory approval process
for product candidates, and risks associated with being in both the
diagnostic and therapeutic businesses. Further information about
these and other risks is included in Adeza's Annual Report on Form
10-K and other periodic and current reports filed by Adeza with the
Securities Exchange Commission (SEC), which are available from the
SEC's Web site (www.sec.gov), and also available on the Investors
section of Adeza's Web site. All forward-looking statements are
qualified in their entirety by this cautionary statement and Adeza
undertakes no obligation to revise or update this news release to
reflect events or circumstances after the date hereof.
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