AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today received a complete
response letter (CRL) from the U.S. Food and Drug Administration
(FDA) for its application seeking approval for a single-dose vial
of Makena (hydroxyprogesterone caproate injection) to reduce the
risk of preterm birth in certain at-risk patients. A CRL is a
communication from the FDA that informs companies that an
application cannot be approved in its present form. In the letter,
the FDA requested additional information and the company is working
with its manufacturer to submit a response with the requested
information to the FDA as quickly as possible.
"While we are disappointed by this delay, we believe the
single-dose, preservative-free vial is an important step in our
next generation development program for Makena, and we remain
committed to working with the FDA to bring this product to market,"
stated William Heiden, chief executive officer of AMAG. "Improving
the healthcare provider and patient experience with Makena through
the development of customer-friendly line extensions is a key
priority for the company."
Makena, the only FDA-approved treatment indicated to reduce the
risk of preterm birth in women who are pregnant with one baby and
who have spontaneously delivered one preterm baby in the past, is
currently marketed in a multi-dose vial, containing five weekly
injections. The multi-dose Makena vial remains available for
prescribing and is not affected by the letter from FDA regarding
the single-dose application.
For more information about Makena, visit www.makena.com.
About Makena® (hydroxyprogesterone caproate
injection)
Makena® is a progestin indicated to reduce the risk of preterm
birth in women with a singleton pregnancy who have a history of
singleton spontaneous preterm birth. The effectiveness of Makena is
based on improvement in the proportion of women who delivered
<37 weeks of gestation. There are no controlled trials
demonstrating a direct clinical benefit, such as improvement in
neonatal mortality and morbidity.
Limitation 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.
Important Safety Information for Makena
(hydroxyprogesterone caproate injection)
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.
In one clinical study, certain complications or events
associated with pregnancy occurred more often in women who received
Makena. These included miscarriage (pregnancy loss before 20 weeks
of pregnancy), stillbirth (fetal death occurring during or after
the 20th week of pregnancy), hospital admission for preterm labor,
preeclampsia (high blood pressure and too much protein in the
urine), gestational hypertension (high blood pressure caused by
pregnancy), gestational diabetes, and oligohydramnios (low amniotic
fluid levels).
Makena may cause serious side effects including blood clots,
allergic reactions, depression, and yellowing of the skin and the
whites of the eyes. The most common side effects of Makena include
injection site reactions (pain, swelling, itching, bruising, or a
hard bump), hives, itching, nausea, and diarrhea.
For additional U.S. product information, including full
prescribing information, please visit www.makena.com.
About AMAG
AMAG Pharmaceuticals uses its business and clinical expertise to
develop and commercialize therapeutics that provide clear benefits
and improve people's lives. Based in Waltham, Mass., AMAG has a
diverse portfolio of products in the areas of maternal health,
anemia management and cancer supportive care. AMAG continues to
work to expand the impact of these and future products for patients
by delivering on its aggressive growth strategy, which includes
organic growth, as well as the pursuit of products and companies
that align with AMAG's existing therapeutic areas or those that
could benefit from its proven core competencies. For additional
company information, please visit www.amagpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
(PSLRA) and other federal securities laws. Any statements contained
herein which do not describe historical facts, including, among
others, AMAG's expectations regarding its response to the FDA;
statements regarding the benefits of the single-dose vial of Makena
to healthcare providers and patients; AMAG's ability to provide
clear benefits and improve people's lives; and plans to expand and
diversify AMAG's portfolio 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, 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, 2014, its Quarterly Reports on Form 10-Q
for the quarters ended June 30, 2015 and September 30, 2015 and
subsequent filings with the SEC. 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® is a registered trademark of AMAG
Pharmaceuticals, Inc. Makena® is a registered trademark of Lumara
Health Inc.
CONTACT: Linda Lennox
Vice President, Investor Relations & Corporate Communications
617-498-2846
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