Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births
18 Julio 2006 - 3:00AM
Business Wire
Adeza (NASDAQ:ADZA) today announced that its New Drug Application
(NDA) for Gestiva(TM) will be reviewed by the Reproductive Health
Drugs Advisory Committee to the U.S. Food and Drug Administration
(FDA) on August 29, 2006. Gestiva, a long acting form of a
naturally occurring progesterone, is the company's drug candidate
to prevent preterm birth in women with a history of preterm
delivery. "The setting of an advisory committee meeting date marks
an important next step in the Gestiva NDA review process," said
Emory V. Anderson, president and chief executive officer. "A
preterm birth occurs nearly every minute and imposes a $26 billion
annual cost to the U.S. health care system. For the cases involving
women with a prior history of preterm delivery, we believe Gestiva
can help reduce costs by prolonging pregnancy and preventing
preterm births." In May 2006, Adeza announced the submission of its
Gestiva NDA under Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act. Adeza was subsequently granted Priority Review for
the Gestiva NDA and, pursuant to Prescription Drug User Fee Act
(PDUFA) guidelines, the FDA has set a goal to complete its review
or otherwise respond to Adeza on the Gestiva NDA by October 20,
2006. Priority Review is granted to product candidates that, if
approved, would provide a significant improvement in the treatment,
diagnosis or prevention of a disease. The Gestiva NDA includes
positive data from a 463-patient clinical study with 17
alpha-hydroxyprogesterone caproate (17P) in pregnant women with a
history of preterm birth conducted by the National Institute of
Child Health and Human Development, one of the institutes of the
National Institutes of Health (NIH). 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. In 2003 the
American College of Obstetricians and Gynecologists (ACOG) issued a
recommendation for the use of progesterone in women with a history
of prior preterm birth to help prevent preterm delivery, following
publication of NIH study results in the June 2003 New England
Journal of Medicine. 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. 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 are forward-looking statements,
including for example, statements related to Gestiva's regulatory
status and medical potential. 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 related to the anticipated regulatory or
commercial path for its product candidates. Further information
about these and other risks is included Adeza's Annual Report on
Form 10-K and other periodic and current reports filed by Adeza
with the Securities Exchange Commission, which are available from
the SEC's Web site (www.sec.gov), and also available on the
Investor Relations 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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