FDA Advisory Committee Recommends Approval of Adeza's NDA for Gestiva to Prevent Preterm Birth
29 Agosto 2006 - 8:33PM
Business Wire
Adeza (NASDAQ:ADZA) today announced that the Reproductive Health
Drugs Advisory Committee to the U.S. Food and Drug Administration
(FDA) recommended by a majority vote that the data presented by
Adeza in its New Drug Application (NDA) for Gestiva(TM) 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 Advisory Committee also recommended the collection of
post marketing clinical data. Although Advisory Committee
recommendations are not binding, typically FDA final determinations
are consistent with their recommendations. Pursuant to Prescription
Drug User Fee Act (PDUFA) guidelines, the FDA has a goal to
complete its review or otherwise respond to the Gestiva NDA by
October 20, 2006. "We are pleased by the Advisory Committee's
support for this important therapeutic for the prevention of
preterm birth in women with a history of preterm delivery," said
Emory V. Anderson, president and chief executive officer. "With
approximately one preterm birth every minute and a $26 billion
annual cost to the U.S. health care system, preterm birth is a
major public health issue. Treating women with a history of preterm
birth with Gestiva could considerably reduce preterm birth and the
associated costs for this high risk group." Gestiva is a
long-acting form of a naturally occurring progesterone. 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. 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. In
June 2006, Adeza's NDA for Gestiva was granted Priority Review
status. 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 National
Institutes of Health (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
in 19 clinical trial centers. 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, as reported in the June, 2003 New
England Journal of Medicine, 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 serious
complications such as necrotizing enterocolitis, intraventricular
hemorrhage, use of supplemental oxygen, and mean number of days of
respiratory therapy. About Adeza 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 its NDA to 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 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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