Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced the
U.S. Food and Drug Administration (FDA) has approved the
supplemental new drug application (sNDA) to expand the indication
of ZORYVE (roflumilast) cream 0.3% for the topical treatment of
plaque psoriasis, including intertriginous areas, to children ages
6 to 11 years. ZORYVE, a once-daily, steroid-free cream that is
effective, safe, and well tolerated, is designed to simplify
management of plaque psoriasis.
“Young children with plaque psoriasis lack treatment options,
which is why today’s decision by the FDA represents a meaningful
advancement for this pediatric population, their parents, and
caregivers,” said Patrick Burnett, MD, PhD, FAAD, chief medical
officer at Arcutis. “ZORYVE has been shown to be safe, well
tolerated, and effective; all critical factors for treating
children with plaque psoriasis. We are excited to now be able to
expand the availability of ZORYVE to children as young as 6 years
old, offering them and their families an important new steroid-free
treatment option to consider along with their healthcare
providers.”
As with adults and adolescents, plaque psoriasis is the most
common form of psoriasis in children 6 to 11 years of age, and
presents with very similar clinical features, including “plaques,”
or raised, red areas of skin covered with a silver or white layer
of dead skin cells. Plaques in sensitive areas, where the skin may
be thinner or more sensitive, pose specific treatment
challenges.
“In children, psoriasis ranges from mild to severe, and more
often appears on sensitive areas including the face and skin folds,
compared to adults. Topical steroids are commonly recommended
medications for the treatment of pediatric psoriasis. However, they
come with safety and tolerability concerns related to long-term
use. Steroid-free topical treatments that can be used on sensitive
areas are especially needed for managing plaque psoriasis in
younger children,” said Adelaide A. Hebert, MD, professor and chief
of pediatric dermatology at McGovern Medical School at UTHealth
Houston and Children’s Memorial Hermann. “In clinical studies with
ZORYVE in the pediatric population, efficacy was consistent with
the pivotal Phase 3 DERMIS-1 and DERMIS-2 trial results in adults.
In addition, ZORYVE was shown to be safe and well tolerated, an
important consideration for managing plaque psoriasis, especially
in children.”
ZORYVE is the only topical treatment for which efficacy in
intertriginous areas (skin folds) was evaluated in the pivotal
trials and the only product specifically indicated for use in these
areas. A non-greasy, moisturizing cream that absorbs quickly and
spreads easily, ZORYVE does not include sensitizing excipients or
irritants such as propylene glycol, polyethylene glycol, isopropyl
alcohol, ethanol, or fragrances.
“Psoriasis is the second most common inflammatory skin disease
in children, and it can significantly affect the quality of life of
the child, their family members, and caregivers,” said Leah M.
Howard, JD, president and CEO of the National Psoriasis Foundation.
“We are told by the experts that advise us that there are numerous
challenges when it comes to treating children, and finding the
right treatment regimen can be difficult, which is why we are
encouraged by the advancements being made to alleviate the burden
of disease for this population.”
The approval of the expanded indication is based on data from a
4-week Maximal Usage Systemic Exposure (MUSE) study in children
ages 6 to 11 years with plaque psoriasis. Pharmacokinetic, safety,
tolerability, and efficacy data from this study were generally
consistent with data from the DERMIS-1 and DERMIS-2 pivotal Phase 3
trials in adults. Results from a second MUSE study, in children
ages 2 to 5 years, as well as data from an ongoing open label
extension study to assess the long-term safety of roflumilast cream
0.3% in individuals with plaque psoriasis 2 years of age and older
(ARQ-151-306), will be the subject of a future FDA review.
A Media Snippet accompanying this announcement is available by
clicking on the image or link below:
About PsoriasisPsoriasis is a common,
non-contagious, immune-mediated skin disease that affects
approximately nine million people in the United States. The
majority of individuals with psoriasis develop “plaques,” or
raised, red areas of skin covered with a silver or white layer of
dead skin cells. The plaques’ clinical presentation may have more
grayish, purplish, or brownish tones in people with darker skin
tones. Psoriatic plaques are often itchy and sometimes painful and
can appear on any area of the body. Plaques in certain anatomical
areas present unique treatment challenges, including the face,
elbows and knees, scalp, and intertriginous areas (where two skin
areas may touch or rub together), such as armpits, under the
breasts, groin, and stomach folds.
About ZORYVE®ZORYVE
(roflumilast) cream 0.3% is indicated for topical treatment of
plaque psoriasis, including intertriginous areas, in patients 6
years of age and older.
IMPORTANT SAFETY INFORMATION ZORYVE is
contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
The most common adverse reactions (≥1%) include diarrhea (3.1%),
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%).
Please see full Prescribing Information.
ZORYVE is for topical use only and not for ophthalmic, oral, or
intervaginal use.
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 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 for ZORYVE to
simplify disease management for care of plaque psoriasis, including
in children, the potential for roflumilast to gain an expanded
approval for the treatment of children ages 2-5 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 28, 2023, 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
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