AMAG Pharmaceuticals Announces the Publication of the PROLONG Trial Evaluating 17-OHPC in the American Journal of Perinatolog...
October 25 2019 - 10:19AM
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the
results of PROLONG (Progestin’s Role in Optimizing Neonatal
Gestation) were published online in the American Journal of
Perinatology. PROLONG was a randomized, double-blind,
placebo-controlled clinical trial evaluating
17-OHPC (17-α-hydroxyprogesterone caproate or Makena®) in
patients with a history of a prior spontaneous singleton preterm
delivery. The PROLONG trial was conducted as part of an approval
commitment under the Food & Drug Administration’s (FDA)
“Subpart H” accelerated approval process.
As previously announced, the PROLONG trial did not meet the two
pre-specified co-primary endpoints of a reduction of preterm birth
(defined as less than 35 weeks of gestation) and a reduction in the
neonatal morbidity and mortality index, in contrast to the original
Meis trial results published in the New England Journal of
Medicine. PROLONG reaffirmed that the 17-OHPC safety profile is
comparable to placebo.
The FDA will hold a meeting of the Bone, Reproductive and
Urologic Drugs Advisory Committee (BRUDAC) on October 29, 2019, to
better understand and interpret the PROLONG trial data.
About Makena® (hydroxyprogesterone caproate
injection)
Makena is a progestin indicated to reduce the risk of preterm
birth in women pregnant with a single baby who have a history of
singleton spontaneous preterm birth. Makena was approved by
the FDA in February 2011 and was granted orphan drug exclusivity
through February 3, 2018. In February of 2018, AMAG introduced
the prefilled Makena auto-injector containing a short, thin,
non-visible needle for subcutaneous use, offering patients and
providers a new administration option.
Makena has certain limitations of use. While there are many risk
factors for preterm birth, safety and efficacy of Makena has been
demonstrated only in women with a prior spontaneous singleton
preterm birth. It is not intended for use in women
with multiple gestations or other risk factors for preterm
birth.
Makena should not be used in women with any of the following
conditions: blood clots or other blood clotting problems, breast
cancer or other hormone-sensitive cancers, or history of these
conditions; unusual vaginal bleeding not related to the current
pregnancy, yellowing of the skin due to liver problems during
pregnancy, liver problems, including liver tumors, or uncontrolled
high blood pressure. Before patients receive Makena, they should
tell their healthcare provider if they have an allergy to
hydroxyprogesterone caproate, castor oil, or any of the other
ingredients in Makena; diabetes or prediabetes, epilepsy, migraine
headaches, asthma, heart problems, kidney problems, depression, or
high blood pressure.
For additional product information, including full prescribing
information, please visit www.makena.com.
About AMAGAMAG is a pharmaceutical
company focused on bringing innovative products to patients with
unmet medical needs. The company does this by leveraging its
development and commercial expertise to invest in and grow its
pharmaceutical products across a range of therapeutic areas,
including women’s health. For additional company information,
please visit www.amagpharma.com.
Forward-Looking Statements This
press release contains forward-looking information about AMAG
within the meaning of the Private Securities Litigation Reform Act
of 1995 and other federal securities laws. Any statements contained
herein which do not describe historical facts, including, among
others, the perceived relationship between the Meis trial and
PROLONG trial; and how the FDA will interpret the PROLONG data are
forward-looking statements which involve risks and uncertainties
that could cause actual results to differ materially from those
discussed in such forward-looking statements. Such risks and
uncertainties include, among others, the risk that the Makena
franchise is currently solely dependent on sales from the Makena
auto-injector in light of the company’s exit from the Makena IM
market, and the Makena auto-injector may not be successful,
including if (i) AMAG is unsuccessful in convincing patients to use
or healthcare providers to prescribe the Makena auto-injector
product or (ii) the FDA takes adverse action related to
Makena in response to the results of the PROLONG study and the
FDA’s ongoing review, including following the Advisory Committee
meeting scheduled November 29, 2019; as well as those risks
identified in AMAG’s filings with the U.S. Securities and
Exchange Commission (SEC), including its Annual Report on Form
10-K for the year ended December 31, 2018, its Quarterly
Report on Form 10-Q for the quarters ended March 31,
2019 and June 30, 2019 and subsequent filings with
the U.S. Securities and Exchange Commission (the “SEC”),
which are available at the SEC’s website at www.sec.gov. Any
such risks and uncertainties could materially and adversely affect
AMAG’s results of operations, its profitability and its cash flows,
which would, in turn, have a significant and adverse impact on
AMAG’s stock price. AMAG cautions you not to place undue reliance
on any forward-looking statements, which speak only as of the date
they are made. AMAG disclaims any obligation to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements.
AMAG Pharmaceuticals® and the logo are registered trademarks
of AMAG Pharmaceuticals, Inc. Makena® is a registered
trademark of AMAG Pharma USA, Inc.
AMAG Pharmaceuticals Contacts: Investors: Linda
Lennox908-627-3424
Media: Sarah Connors 781-296-0722
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