AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the
U.S. Food and Drug Administration’s (FDA) Bone, Reproductive and
Urologic Drugs Advisory Committee met to better understand and
interpret the PROLONG (Progestin’s Role in Optimizing Neonatal
Gestation) confirmatory clinical trial for Makena®
(hydroxyprogesterone caproate injection), a treatment approved to
reduce preterm birth in pregnant women who have had a prior
spontaneous preterm birth. While the committee discussed multiple
questions, in a mixed vote on the key question, nine advisory
committee members voted to recommend that the FDA pursue withdrawal
of approval for Makena and seven committee members voted to leave
the product on the market under accelerated approval and require a
new confirmatory trial. Among the clinicians on the advisory
committee, five of the six who practice obstetrics voted to keep
Makena on the market and generate more data. AMAG agrees with
several committee members who voiced concern that withdrawal of
Makena would leave providers with no safe treatment options for
pregnant women. The advisory committee's recommendation, while not
binding, will be considered by the FDA in making its decision.
“We are disappointed with the nearly split vote on this key
question and we are committed to working with the FDA to identify
feasible ways to generate additional efficacy data on Makena while
retaining current access to the therapy for at-risk pregnant
women,” said Julie Krop, M.D., chief medical officer at AMAG.
“Preterm birth is an urgent public health crisis and the
implications of leaving pregnant women and providers without access
to therapy that is manufactured in a safe and regulated way is
profoundly troubling. For more than a decade, healthcare providers
have relied on hydroxyprogesterone caproate to reduce preterm
delivery in high-risk patients, which aligns with recently updated
treatment recommendations of the American College of Obstetricians
and Gynecologists, as well as the Society for Maternal-Fetal
Medicine.”
Makena’s active ingredient, 17α hydroxyprogesterone caproate
(often referred to as 17P), is the only FDA-approved treatment for
pregnant women who have had a prior spontaneous preterm birth
(which is a substantial risk factor for recurrent preterm birth).1
17P has been recognized as the standard of care and used for more
than a decade by healthcare providers to treat patients with a
history of spontaneous preterm birth,2 which represents
approximately 130,000 births a year in the United States.3
The approval of Makena was based on the landmark Meis trial,
conducted by the National Institute of Child Health and Human
Development and the Maternal-Fetal Medicine Units Network and
published in the New England Journal of Medicine in 2003. The
PROLONG trial was later conducted as part of an FDA approval
commitment. Comprised of more than 1,700 pregnant women, PROLONG
represents the largest trial of any progestogen studied for preterm
birth prevention and is also the largest trial of a drug treating
an orphan condition. It enrolled more than 75 percent of its
patients from outside of the U.S., which was necessary given the
routine use of 17P as the standard of care.
1 Iams JD, Goldenberg RL, Mercer BM, et al. The Preterm
Prediction Study: recurrence risk of spontaneous preterm birth.
National Institute of Child Health and Human Development
Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol. May
1998;178(5):1035-1040.2 Society for Maternal-Fetal Medicine
Publications Committee, with the assistance of Vincenzo Berghella,
MD. AJOG. https://www.ajog.org/article/S0002-9378(12)00291-8/pdf3
Petrini JR, CallaghanWM, Klebanoff M, et al. Estimated effect of 17
alpha-hydroxyprogesterone caproate on preterm birth in the United
States. Obstet Gynecol 2005;105(02):267–272
AMAG will provide a corporate update and discuss the company's
third quarter financial results on a conference call on November 1,
2019 at 8:00 AM ET. The live webcast can be accessed on the
investor page of AMAG's website at www.amagpharma.com. The
conference call can be accessed by dialing (877) 412-6083
(U.S./Canada) or (702) 495-1202 (international). Use conference ID
6261528 for both domestic and international numbers. A replay of
the webcast will be available on AMAG's website
approximately two hours after completion of the event and will
be archived for up to 30 days.
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 StatementsThis 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, AMAG’s
ability to identify ways to generate additional efficacy data on
Makena and retain current access to the therapy for at-risk
pregnant women, AMAG’s plans to work with the FDA, beliefs about
the size of the patient population for Makena and the belief that
withdrawal of 17P would leave providers with no safe treatment
options for pregnant women 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 (i) the FDA takes adverse action related to Makena,
including withdrawal of the product from the market, especially
given the findings and recommendation of the Advisory Committee
meeting that approval of 17P be withdrawn, (ii) AMAG may not be
able to generate additional efficacy data that will be satisfactory
to the FDA, or (iii) healthcare providers will no longer prescribe
the Makena auto-injector product even if it were to remain
commercially available; 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 SEC, including its
upcoming Quarterly Report on Form 10-Q for the quarter ended
September 30, 2019, 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:Rushmie Nofsinger781-530-6838
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