FDA assigns PDUFA target action date of
March 8, 2024
New Drug Application supported by positive
Phase III efficacy and safety clinical trial results
Milestone builds upon Viatris' long-standing
and continued commitment toward addressing the unmet needs of the
MS community
PITTSBURGH and NESS ZIONA, Israel, Aug. 7, 2023
/PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global
healthcare company, and Mapi Pharma Ltd., a fully integrated,
late-stage clinical development pharmaceutical company,
today announced that the U.S. Food and Drug Administration
(FDA) has accepted for review the companies' recently submitted New
Drug Application (NDA) for GA Depot 40 mg. The product is a
long-acting glatiramer acetate being investigated as a once-monthly
injection for the treatment of relapsing forms of multiple
sclerosis (RMS). The FDA has assigned a Prescription Drug User Fee
Act (PDUFA) action date of March 8,
2024.
Viatris President Rajiv
Malik said, "The NDA filing acceptance for GA Depot is
yet another example of our continuous commitment to look for
opportunities to enhance existing therapies and innovation to
support unmet medical needs. Our application is backed by Phase III
efficacy and safety data, and we believe, when approved, GA Depot
could improve patient experience through fewer injections, greater
tolerability and increased compliance. This milestone gives us
further confidence in the strength of our GA Depot clinical
program, and we look forward to continuing to work closely with FDA
to bring access to this important complex medicine to
patients."
According to a landmark study funded by the National Multiple
Sclerosis Society, nearly one million people are living with MS in
the U.S., which is more than twice as many people than was
previously thought.1 Approximately 85 percent of people
with MS are initially diagnosed with relapsing-remitting multiple
sclerosis.2
The GA Depot NDA filing is supported by results from a
multinational, double blind, placebo-controlled Phase III clinical
trial evaluating the efficacy, safety and tolerability of GA Depot
compared with placebo in patients with RMS. A total of 1,016
subjects were randomized into two groups, receiving either 40mg of
GA Depot or placebo, via intramuscular injection (IM), once every 4
weeks for a total of 13 doses. The study concluded that the product
offers a preferable schedule and with expected fewer Injection Site
Reactions than other GA products. The study met its primary
endpoint showing that GA Depot 40 mg statistically significantly
reduced the annualized relapse rate by 30.1 percent compared to
placebo (p=0.0066).
"We are confident that GA Depot, when approved, will represent
an important advancement in MS care by offering a convenient
once-monthly option for patients which may potentially improve
compliance and adherence, and the medicine is well positioned to
deliver on this important unmet need," said Ehud Marom, CEO and Chairman, Mapi Pharma. "I commend the teams at Mapi and
Viatris for the strong collaboration which has leveraged our
collective expertise in complex products to deliver this novel
medicine."
About GA Depot
GA Depot is a long-acting injection
version of the approved Glatiramer Acetate (GA, commercially
available as Copaxone®), designed to be administered as an
intramuscular injection once every four weeks. GA Depot is intended
to be used for treatment of Relapsing forms of Multiple Sclerosis
(RMS). GA Depot is also currently being tested in Phase II for
Primary Progressive Multiple Sclerosis (PPMS).
References:
-
https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS/How-Many-People
-
https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a
global healthcare company empowering people worldwide to live
healthier at every stage of life. We provide access to medicines,
advance sustainable operations, develop innovative solutions and
leverage our collective expertise to connect more people to more
products and services through our one-of-a-kind Global Healthcare
Gateway®. Formed in November 2020, Viatris brings together
scientific, manufacturing and distribution expertise with proven
regulatory, medical, and commercial capabilities to deliver
high-quality medicines to patients in more than 165 countries and
territories. Viatris' portfolio comprises more than 1,400 approved
molecules across a wide range of therapeutic areas, spanning both
non-communicable and infectious diseases, including globally
recognized brands, complex generic and branded medicines, and a
variety of over-the-counter consumer products. With more than
38,000 colleagues globally, Viatris is headquartered in the U.S.,
with global centers
in Pittsburgh, Shanghai and Hyderabad,
India. Learn more
at viatris.com and investor.viatris.com, and connect
with us on Twitter, LinkedIn, Instagram and
YouTube.
About Mapi Pharma
Mapi Pharma is a clinical
stage pharmaceutical company, engaged in development of
high barrier-to-entry and high added-value life cycle
management ("LCM") products and AB Rated Depot injectable products
that target large markets that include complex active
pharmaceutical ingredients ("APIs") and formulations. Mapi Pharma
partnered with Viatris for GA Depot in an agreement under which
Viatris was granted an exclusive license to commercialize the GA
Depot injection product for relapsing forms of multiple sclerosis.
The Company is also marketing its own generic versions of
Fingolimod (Gilenya®) and Apremilast
(Otezla®) in specific geographic markets. Mapi's
portfolio also includes a leading development of Depot drugs for
Schizophrenia, GLP-1 for diabetes, weight control, Parkinson's
disease and potentially Alzheimer's with innovative intellectual
property. Mapi is built on strong chemical and pharmaceutical
R&D capabilities, a deep understanding of the global market and
of regulatory needs. Mapi is headquartered in Israel,
with R&D facilities in Israel and
China, and an API production facility, and an aseptic
manufacturing and a Fill & Finish facility for injectable
Finished Dosage Forms, all in Israel. Mapi has a strong IP
position, filing numerous patent applications for APIs and
formulations. For more information, please
visit www.mapi-pharma.com.
Forward-Looking Statements
This press release includes statements that constitute
"forward-looking statements." These statements are made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward looking statements may include
statements regarding FDA acceptance of NDA filing for GA Depot for
the treatment of relapsing forms of multiple sclerosis; FDA assigns
PDUFA target action date of March 8,
2024; the NDA filing acceptance for GA Depot is yet another
example of our continuous commitment to look for opportunities to
enhance existing therapies and innovation to support unmet medical
needs; our application is backed by Phase III efficacy and safety
data, and we believe, when approved, GA Depot could improve patient
experience through fewer injections, greater tolerability and
increased compliance; this milestone gives us further confidence in
the strength of our GA Depot clinical program, and we look forward
to continuing to work closely with FDA to bring access to this
important complex medicine to patients. Factors that could cause or
contribute to such differences include, but are not limited to: the
possibility that the Company may be unable to realize the intended
benefits of, or achieve the intended goals or outlooks with respect
to, its strategic initiatives; the possibility that the Company may
be unable to achieve expected benefits, synergies and operating
efficiencies in connection with acquisitions, divestitures, or its
global restructuring program, within the expected timeframe or at
all; impairment charges or other losses related to the divestiture
or sale of businesses or assets; the Company's failure to achieve
expected or targeted future financial and operating performance and
results; the potential impact of public health outbreaks, epidemics
and pandemics, including the ongoing challenges and uncertainties
posed by COVID-19; actions and decisions of healthcare and
pharmaceutical regulators; changes in healthcare and pharmaceutical
laws and regulations in the U.S. and abroad; any regulatory, legal
or other impediments to Viatris' ability to bring new products to
market, including but not limited to "at-risk" launches; Viatris'
or its partners' ability to develop, manufacture, and commercialize
products; the scope, timing and outcome of any ongoing legal
proceedings, and the impact of any such proceedings; any
significant breach of data security or data privacy or disruptions
to our information technology systems; risks associated with
international operations; the ability to protect intellectual
property and preserve intellectual property rights; changes in
third-party relationships; the effect of any changes in Viatris' or
its partners' customer and supplier relationships and customer
purchasing patterns; the impacts of competition; changes in the
economic and financial conditions of Viatris or its partners;
uncertainties and matters beyond the control of management,
including general economic conditions, inflation and exchange
rates; failure to execute stock repurchases consistent with current
expectations; stock price volatility; and the other risks described
in Viatris' filings with the Securities and Exchange Commission
(SEC). Viatris routinely uses its website as a means of disclosing
material information to the public in a broad, non-exclusionary
manner for purposes of the SEC's Regulation Fair Disclosure (Reg
FD). Viatris undertakes no obligation to update these statements
for revisions or changes after the date of this release other than
as required by law.
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