Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% for Expanded Indication for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age
20 December 2022 - 12:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early
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 the expanded indication
of ZORYVE (roflumilast) cream 0.3% for the treatment of plaque
psoriasis in children ages 2 to 11. As with adults and adolescents,
plaque psoriasis is the most common form of psoriasis in children 2
to 11 years of age, with very similar clinical features.
ZORYVE was approved by the FDA in July 2022 for the topical
treatment of plaque psoriasis in adults and adolescents 12 years of
age and older. ZORYVE is a steroid-free, topical PDE4 inhibitor
which effectively clears plaque psoriasis in both hard-to-treat
areas such as knees and elbows, as well as sensitive areas such as
the face, intertriginous areas, and genitalia.
“Safety and tolerability are critically important in the
treatment of children, and today young children lack treatment
options for plaque psoriasis. This submission is an exciting step
in our efforts to expand the availability of an effective,
steroid-free treatment for children with plaque psoriasis,” said
Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis.
“ZORYVE is the first PDE4 approved for the treatment of psoriasis
and, if approved by the FDA with the new data, dermatology
clinicians will be able to treat patients down to 2 years of
age.”
“ZORYVE demonstrated a favorable safety and tolerability profile
in this pediatric population, with minimal local site reactions.
ZORYVE, with our proprietary HydroARQ Technology™, is a non-greasy,
moisturizing cream that spreads easily and is aesthetically
pleasing to patients, and most importantly does not include
sensitizing excipients or irritants such as propylene glycol,”
added Frank Watanabe, President and CEO at Arcutis.
The submission is based on data from two recently completed
4-week MUSE studies (NCT04655313 ; NCT04746911) in children aged 2
to 11 years with plaque psoriasis. Pharmacokinetic, safety,
tolerability, and efficacy data from these two studies are
consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase 3
trials. Arcutis worked with the FDA on the design of the MUSE
studies, which are intended to fulfill FDA post-marketing
requirements for ZORYVE.
About ZORYVE® ZORYVE
(roflumilast) cream 0.3% is indicated for topical treatment of
plaque psoriasis, including intertriginous areas, in patients 12
years of age and older.
IMPORTANT SAFETY INFORMATIONThe use of ZORYVE
is contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
The most common adverse reactions (≥1%) include diarrhea (3%),
headache (2%), insomnia (1%), nausea (1%), application site pain
(1%), upper respiratory tract infection (1%), and urinary tract
infection (1%).
Please see full Prescribing Information.
About ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is an early 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 that harnesses 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, atopic
dermatitis, seborrheic dermatitis, and alopecia areata. For more
information, visit www.arcutis.com or follow Arcutis
on LinkedIn, Facebook, and Twitter.
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 for ZORYVE to
simplify disease management for care of plaque psoriasis; the
potential for roflumilast to gain an expanded approval for the
treatment of children ages 2-11 years for plaque psoriasis; the
potential of real-world use results of roflumilast cream, as well
as the commercial launch of ZORYVE in plaque psoriasis. 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 U.S. Securities and
Exchange Commission (SEC) on February 22, 2022, as amended, 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 Communicationsasheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor
Relationsemcintyre@arcutis.com
Arcutis Biotherapeutics (NASDAQ:ARQT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Arcutis Biotherapeutics (NASDAQ:ARQT)
Historical Stock Chart
From Apr 2023 to Apr 2024