Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced the
submission of a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) for ZORYVE
(roflumilast) cream 0.05%, a once-daily, next generation
phosphodiesterase 4 (PDE4) inhibitor, for the topical treatment of
mild to moderate AD in children 2 to 5 years old.
“When choosing a therapy for very young children living with AD,
healthcare providers and caregivers have to account for unique
considerations for pediatric patients, including sensitive skin,
and select a medication that is appropriate for long-term use by a
child with a chronic skin condition. Data from the pivotal trial
demonstrated that roflumilast cream 0.05% provided consistent and
rapid relief, and was well-tolerated,” said Rocco Serrao, MD, FAAD,
of DOCS Dermatology and INTEGUMENT-PED and INTEGUMENT-OLE
investigator. “If approved, roflumilast cream 0.05% would offer a
new topical option with the potential to advance the standard of
care for these young patients, offering fast relief to the children
and their families from the onerous symptoms of AD.”
AD is a chronic, genetically predisposed, relapsing inflammatory
skin disease that presents across the lifespan. The disease may
appear as a red, intensely itchy rash that can occur anywhere on
the body and may present differently in children and adults.
Pediatric AD can negatively impact the quality of life of the child
as well as their family or caregivers.
“Parents, caregivers, and healthcare professionals need to feel
confident in their treatment plan. Our clinical development program
for ZORYVE reinforces the well-established efficacy, safety, and
tolerability profile of roflumilast cream, which was designed to
deliver drug without disrupting the skin barrier or using
sensitizing excipients and irritants. This lower concentration of
roflumilast cream was intentionally formulated for the needs of
younger children with AD and demonstrates our commitment to serving
this vulnerable patient population,” said Frank Watanabe, president
and CEO of Arcutis. “We look forward to the opportunity to offer
ZORYVE cream 0.05%, if approved, as a new topical therapy for the
1.8 million children between the ages of 2 to 5 with AD and their
families.”
The sNDA is supported by positive results from one pivotal Phase
3 trial, one pivotal long-term extension study, as well as a Phase
1 pharmacokinetic study. The INTEGUMENT-PED vehicle-controlled,
pivotal Phase 3 trial enrolled 652 children 2 to 5 years of age,
with a mean AD Body Surface Area (BSA) of 22% overall, and ranging
from 3% to 82%. In the study, at Week 4, 25.4% of children treated
with roflumilast cream 0.05% achieved vIGA-AD Success, defined as a
validated Investigator Global Assessment – Atopic Dermatitis
(vIGA-AD) score of ‘Clear’ or ‘Almost Clear’ plus a 2-grade
improvement from baseline, compared to 10.7% of children treated
with vehicle (P<0.0001), with significant improvements seen as
early as Week 1. All secondary endpoints were also met, with
significant improvements seen across all time points, including
vIGA-AD success and vIGA-AD of ‘Clear’ and ‘Almost Clear’ at Week
1. In addition, 35.3% of children treated with roflumilast cream
who had a baseline Worst Itch Numeric Scale (WI-NRS) score ≥4 (as
reported by the caregiver) achieved a four-point reduction in
WI-NRS at Week 4 (vs. 18.0% for vehicle-treated children [nominal
P=0.0002]).
Roflumilast cream 0.05% was well-tolerated. Overall, the safety
profile observed in 2‑ to 5‑year‑old pediatric subjects treated
with ZORYVE cream 0.05% during the trial was consistent with the
favorable safety profile established in adults and older pediatric
subjects treated with ZORYVE cream 0.15% with mild to moderate AD.
The most frequent adverse events occurring in the roflumilast arm
greater than vehicle (≥2%) included upper respiratory tract
infection, diarrhea, and vomiting.
The submission is also supported by data from the INTEGUMENT-OLE
open-label extension study in which patients ages 2 to 5 (n = 562)
were treated for up to 52 weeks.
About ZORYVE (roflumilast) CreamRoflumilast
cream is a next generation topical PDE4 inhibitor. PDE4 – an
established target in dermatology – is an intracellular enzyme that
increases the production of pro-inflammatory mediators and
decreases production of anti-inflammatory mediators. Roflumilast
cream 0.3% (ZORYVE®) is approved by the FDA for the topical
treatment of plaque psoriasis, including intertriginous areas, in
patients 6 years of age and older. Roflumilast cream 0.15%
(ZORYVE®) is approved by the FDA for the topical treatment of mild
to moderate AD in patients 6 years of age and older. In 2024,
ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness award
for “Eczema Product.”
INDICATIONSZORYVE cream, 0.3%, is indicated for
topical treatment of plaque psoriasis, including intertriginous
areas, in adult and pediatric patients 6 years of age and
older.
ZORYVE cream, 0.15%, is indicated for topical treatment of mild
to moderate atopic dermatitis in adult and pediatric patients 6
years of age and older.
IMPORTANT SAFETY INFORMATIONZORYVE is
contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
The most common adverse reactions (≥1%) for ZORYVE cream 0.3%
for plaque psoriasis include diarrhea (3.1%), headache (2.4%),
insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper
respiratory tract infection (1.0%), and urinary tract infection
(1.0%).
The most common adverse reactions (≥1%) for ZORYVE cream 0.15%
for atopic dermatitis include headache (2.9%), nausea (1.9%),
application site pain (1.5%), diarrhea (1.5%), and vomiting
(1.5%).
Please see full Prescribing Information.
About ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is a commercial-stage medical dermatology company
that champions meaningful innovation to address the urgent needs of
individuals living with immune-mediated dermatological diseases and
conditions. With a commitment to solving the most persistent
patient challenges in dermatology, Arcutis has a growing portfolio
including three FDA approved products that harness our unique
dermatology development platform coupled with our dermatology
expertise to build differentiated therapies against biologically
validated targets. Arcutis’ dermatology development platform
includes a robust pipeline with multiple clinical programs for a
range of inflammatory dermatological conditions including scalp and
body psoriasis, AD, and alopecia areata. For more information,
visit www.arcutis.com or follow Arcutis
on LinkedIn, Facebook, Instagram, and X.
Forward-Looking StatementsArcutis cautions you
that statements contained in this press release regarding matters
that are not historical facts are forward-looking statements. These
statements are based on the Company’s current beliefs and
expectations. Such forward-looking statements include, but are not
limited to, statements regarding the potential FDA approval of
ZORYVE cream 0.05%, the potential of real-world use results of
ZORYVE cream in AD in children aged 2 to 5, and the potential for
ZORYVE cream to advance the standard of care in AD and other
inflammatory dermatological conditions. These statements are
subject to substantial known and unknown risks, uncertainties and
other factors that may cause our actual results, levels of
activity, performance, or achievements to be materially different
from the information expressed or implied by these forward-looking
statements. Risks and uncertainties that may cause our actual
results to differ include risks inherent in our business,
reimbursement and access to our products, the impact of competition
and other important factors discussed in the “Risk
Factors” section of our Form 10-K filed with the U.S.
Securities and Exchange Commission (SEC) on February 27, 2024, as
well as any subsequent filings with the SEC. You should not place
undue reliance on any forward-looking statements in this press
release. We undertake no obligation to revise or update information
herein to reflect events or circumstances in the future, even if
new information becomes available. All forward-looking statements
are qualified in their entirety by this cautionary statement, which
is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
Contacts:MediaAmanda Sheldon, Head of Corporate
Communicationsmedia@arcutis.com
InvestorsLatha Vairavan, Vice President, Finance and Corporate
Controllerir@arcutis.com
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