Momenta Pharmaceuticals Announces Fast Track Designation for M281 (nipocalimab) in Hemolytic Disease of the Fetus and Newborn...
30 July 2019 - 9:00PM
Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology
company focused on discovering and developing novel biologic
therapeutics to treat rare immune-mediated diseases, today
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation for M281, Momenta’s IgG1 monoclonal
antibody targeting FcRn, in Hemolytic Disease of the Fetus and
Newborn (HDFN). HDFN is a serious blood disorder in a fetus or
newborn that occurs when red cell incompatibility exists between
the blood types of a mother and baby.
Additionally, the United States Adopted Names Council (USAN), in
consultation with the World Health Organization (WHO) International
Nonproprietary Names Expert Committee, has adopted nipocalimab as
the nonproprietary (generic) drug name for M281.
“Obtaining Fast Track designation highlights the critical need
for non-invasive, safe and effective treatment options for women at
risk of HDFN. In addition, there is a broad range of rare and
severe allo and autoantibody disorders in maternal fetal medicine
that could benefit from the activity of nipocalimab,” said Craig
Wheeler, President and Chief Executive Officer of Momenta
Pharmaceuticals. “We are pleased to receive Fast Track designation
for nipocalimab in this indication and look forward to continuing
our interactions with the FDA as development progresses.”
HDFN is caused by the transfer of alloantibodies from the
mother's circulatory system to the fetus during pregnancy. This
transfer enables maternal antibodies to attack the red blood cells
of the fetus, resulting in significant morbidity and mortality.
HDFN affects an estimated 4,000 to 8,000 pregnancies each year in
the U.S. with limited options available for treatment. The current
standard-of-care is intrauterine blood transfusions, which are
invasive and may be associated with significant complications.
Nipocalimab (M281), an investigational product, is a fully
human, anti-FcRn, aglycosylated IgG1 monoclonal antibody intended
to reduce the risk and severity of fetal anemia and the resulting
morbidities. Nipocalimab (M281) blocks FcRn-mediated IgG recycling,
thereby reducing the pathogenic alloantibodies in maternal
circulation and blocks placental transfer of maternal IgG,
including pathogenic alloantibodies, to the fetus.
Nipocalimab (M281) is the focus of the Unity clinical trial in
HDFN led by Kenneth Moise, MD, a maternal-fetal medicine specialist
at The University of Texas Health Science Center at Houston
(UTHealth). Moise is the principal investigator for the global
study. He is also a professor in the Department of Obstetrics,
Gynecology, and Reproductive Sciences and Department of Pediatric
Surgery with McGovern Medical School at UTHealth and co-director of
The Fetal Center at Children’s Memorial Hermann Hospital in
collaboration with UT Physicians. McGovern Medical School at
UTHealth is the first site in the U.S. to be open for enrollment in
this global clinical trial. Additional clinical trial information
can be found here.
About the FDA’s Fast Track Program
The FDA’s Fast Track program is designed to facilitate the
development and expedite the review of drugs that treat serious
conditions and fill unmet medical needs. A drug granted Fast Track
Designation may be eligible for several benefits, including more
frequent meetings and communications with the FDA and, if certain
criteria are met, the potential for Accelerated Approval, Priority
Review or Rolling Review of a Biologics License Application
(BLA).
About Momenta
Momenta Pharmaceuticals is a biotechnology company with a
validated innovative scientific platform focused on discovering and
developing novel therapeutics to treat rare, immune-mediated
diseases and advancing its late stage biosimilar portfolio. The
company is headquartered in Cambridge, MA.
To receive additional information about Momenta, please visit
the website at https://www.momentapharma.com/, which does not
form a part of this press release.
The Company’s logo, trademarks, and service marks are the
property of Momenta Pharmaceuticals, Inc. All other trade
names, trademarks, or service marks are property of their
respective owners.
Forward-Looking Statements
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including but not
limited to the timing of regulatory approval and launch of
our product candidates; development timelines; the Company’s
ability to meet its development and strategic goals; market
potential and revenue of our products and product candidates,
design, timing and goals of clinical trials; the use, efficacy,
safety, potency, tolerability, convenience and commercial potential
of our product candidates. Forward-looking statements may be
identified by words such as "believe," "continue," “plan to”,
"potential," "will," and other similar words or expressions, or the
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forward-looking statements involve known and unknown risks,
uncertainties and other important factors, including those referred
to under the section "Risk Factors" in the Company's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2019 filed with
the Securities and Exchange Commission, as well as other
documents that may be filed by the Company from time to time with
the Securities and Exchange Commission. As a result of
such risks, uncertainties and factors, the Company's actual results
may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking
statements contained herein. The Company is providing the
information in this press release as of this date and assumes no
obligations to update the information included in this press
release or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
INVESTOR CONTACT: |
MEDIA CONTACT: |
Patty Eisenhaur |
Karen Sharma |
Momenta Pharmaceuticals |
MacDougall Biomedical
Communications |
1-617-395-5189 |
1-781-235-3060 |
IR@momentapharma.com |
Momenta@macbiocom.com |
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