Sjögren's disease (SjD) is a
prevalent, debilitating autoantibody disease with no
FDA-approved advanced treatments
The Company is actively enrolling patients in
the Phase 3 DAFFODIL study
This marks the fourth nipocalimab FDA Fast
Track designation
SPRING
HOUSE, Pa., March 18,
2025 /PRNewswire/ -- Johnson & Johnson (NYSE:
JNJ) today announced that the U.S. Food and Drug Administration
(FDA) has granted investigational nipocalimab Fast Track
designation (FTD) for the treatment of adult patients with
moderate-to-severe Sjögren's disease (SjD), having previously been
granted Breakthrough Therapy designation (BTD) for the
investigational therapy late last year. Currently, no advanced
therapies are approved to treat this disease.
Building upon the BTD, which nipocalimab is the first and only
therapeutic to receive for SjD, the U.S. FDA's FTD is also
designed to accelerate the delivery of new therapeutics to patients
by facilitating the development and expediting the review of drugs
that demonstrate the potential to treat serious conditions and help
address unmet needs for serious or life-threatening conditions.
"This marks an additional important step forward in our efforts
to bring meaningful advancements to people living with
Sjögren's disease, a serious and debilitating condition. We look
forward to continuing to work closely with the FDA to advance the
clinical development of nipocalimab and potentially provide a
much-needed treatment option for this community," said Katie
Abouzahr, M.D., Vice President, Autoantibody Portfolio
and Maternal Fetal Disease Area Leader, Johnson & Johnson
Innovative Medicine.
There are no FDA-approved treatments that directly address the
underlying causes of this complex disease, associated with serious
health consequences including chronic dryness of moisture producing
glands that may lead to systemic complications such as joint pain,
fatigue and inflammation in multiple organ
systems.1,2,3 These systemic complications can lead
to an increased risk of mortality and associated health conditions,
including a 20 times greater risk of developing B-cell lymphomas
when compared to the general population.1,4
The Phase 2 DAHLIAS study, the results of which were presented
last year, represented the first-ever positive results of an
investigational FcRn blocker as a potential targeted therapy in
SjD. The study achieved the primary endpoint in the 15
mg/kg Q2W nipocalimab group, showing a greater than 70% relative
average improvement in systemic disease activity at Week 24
compared to placebo and IgG reductions of more than
77%.5 Trends of improvement were similarly observed
across multiple secondary endpoints.5 Safety and
tolerability were consistent with other nipocalimab clinical
studies.5
ABOUT SJÖGREN'S DISEASE
Sjögren's disease (SjD) is one of the most prevalent
autoantibody-driven diseases for which no therapies are currently
approved that treat the underlying and systemic nature of the
disease.1 It is a chronic autoimmune disease that
is estimated to impact approximately four million people worldwide
and is nine times more common in women than
men.6,7 SjD is characterized by autoantibody
production, chronic inflammation, and lymphocytic infiltration of
exocrine glands. Most patients are affected by mucosal dryness
(eyes, mouth, vagina), joint pain and
fatigue.1 More than 50% of SjD patients have a
moderate to severe form of the condition, and disease burden can be
as high as that of rheumatoid arthritis or systemic lupus
erythematosus. It is usually associated with impaired quality of
life and functional capacity.6.8,9
ABOUT DAHLIAS
DAHLIAS (NCT04968912) is a Phase 2 multicenter, randomized,
placebo-controlled double-blind study to evaluate the effects of
nipocalimab in participants with primary Sjögren's disease. DAHLIAS
is a Phase 2 dose-ranging study for adults with
moderately-to-severely active primary SjD who were seropositive for
anti-Ro60 and/or anti-Ro52 IgG antibodies. 163 adults aged 18-75
were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15
mg/kg or placebo every 2 weeks through Week 22 and received
protocol-permitted background standard of care. Safety assessments
were conducted through Week 30. The primary endpoint was change in
baseline in the ClinESSDAI (Clinical European League Against
Rheumatism Sjögren's Syndrome Disease Activity Index) Score at Week
24. ClinESSDAI is a systemic diseases activity index designed to
measure disease activity in patients with primary SjD based on 11
domains including: constitutional, lymphadenopathy, glandular,
articular, cutaneous, respiratory, renal, muscular, peripheral
nervous system, central nervous system, and
hematological.
ABOUT NIPOCALIMAB
Nipocalimab is an investigational monoclonal antibody, designed
to bind with high affinity to block FcRn and reduce levels of
circulating immunoglobulin G (IgG) antibodies potentially without
impact on other immune functions. This includes autoantibodies and
alloantibodies that underlie multiple conditions across three key
segments in the autoantibody space including Rare Autoantibody
diseases, Maternal Fetal diseases mediated by maternal
alloantibodies and Rheumatic
diseases.5,10,11,12,13,14,15,16.17 Blockade of IgG
binding to FcRn in the placenta is also believed to limit
transplacental transfer of maternal alloantibodies to the
fetus.18,19
The U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) have granted several key designations to
nipocalimab including:
- U.S. FDA Fast Track designation in hemolytic disease of the
fetus and newborn (HDFN) and warm autoimmune hemolytic anemia
(wAIHA) in July 2019, gMG in
December 2021 and fetal neonatal
alloimmune thrombocytopenia (FNAIT) in March
2024 and Sjögren’s disease (SjD) in March 2025
- U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February
2021, chronic inflammatory demyelinating polyneuropathy
(CIDP) in October 2021 and FNAIT in
December 2023
- U.S. FDA Breakthrough Therapy designation for HDFN in
February 2024 and for Sjögren's
disease in November 2024
- U.S. FDA granted Priority Review in gMG in Q4 2024
- EU EMA Orphan medicinal product designation for HDFN in
October 2019
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build
a world where complex diseases are prevented, treated, and
cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in
Innovative Medicine and MedTech, we are uniquely positioned to
innovate across the full spectrum of healthcare solutions today to
deliver the breakthroughs of tomorrow and profoundly impact health
for humanity.
Learn more at https://www.jnj.com/ or at
https://innovativemedicine.jnj.com/
Follow us at @JNJInnovMed.
Janssen Research & Development, LLC and Janssen Biotech,
Inc. are Johnson & Johnson companies.
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits and
treatment impact of nipocalimab. The reader is cautioned not to
rely on these forward-looking statements. These statements are
based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of Janssen Research &
Development, LLC, Janssen Biotech, Inc. and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's most recent Annual Report on Form 10-K, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. Copies of
these filings are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. None of
Janssen Research & Development, LLC, Janssen Biotech, Inc. nor
Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
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Media contact:
Bridget
Kimmel
bkimmel@its.jnj.com
Investor contact:
Lauren
Johnson
investor-relations@its.jnj.com
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