Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early
commercial-stage company focused on developing meaningful
innovations in immuno-dermatology, today announced the U.S. Food
and Drug Administration (FDA) has approved the new drug application
(NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment
of seborrheic dermatitis in individuals 9 years of age and older.
ZORYVE foam provides rapid disease clearance and significant
reduction in itch, with nearly 80% of individuals achieving the
primary efficacy endpoint of IGA Success and just over 50% of
individuals reaching complete clearance at Week 8 in the STRATUM
trial. ZORYVE is a once-daily steroid-free foam and the first drug
approved for seborrheic dermatitis with a new mechanism of action
in over two decades.
“We know from dermatology clinicians and those living with
seborrheic dermatitis that there has been a real struggle with
disease clearance and treatment adherence due to lack of efficacy,
difficulty treating certain body areas, inconvenient treatment
regimens, and concerns about safety with long-term use,” said
Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis.
“ZORYVE foam is a once-daily, steroid-free topical treatment that
can be used anywhere on the body, including hair-bearing areas,
with no limitation on duration of use. We are proud to deliver
meaningful innovation through this approval of ZORYVE foam, and to
offer a new topical treatment that effectively clears and controls
the disease and can simplify its management for the millions of
adults and adolescents living with seborrheic dermatitis.”
Seborrheic dermatitis affects more than 10 million people in the
United States, and is a common, chronic, and recurrent inflammatory
skin disease that causes red patches covered with large, greasy,
flaking yellow-gray scales, and persistent itch. In individuals
with darker skin tones, inflamed areas may not appear red, but
instead can appear pink, slightly purple, or lighter in color than
the surrounding skin. It occurs most often in areas of the body
with oil-producing (sebaceous) glands, including the scalp, face
(especially on the nose, eyebrows, ears, and eyelids), upper chest,
and back. Hair-bearing areas make applying topicals like creams,
gels, and ointments difficult.
“In the STRATUM trial, ZORYVE foam provided rapid
disease clearance as early as Week 2 and significant itch relief in
as little as 48 hours. In addition, almost 80% of patients achieved
treatment success at Week 8. While multiple factors contribute
to seborrheic dermatitis, inflammation and skin barrier
dysfunction play key roles. ZORYVE has been shown to
effectively reduce the signs of inflammation, redness, and scaling
in patients with seborrheic dermatitis, and with its unique
formulation, ZORYVE foam effectively delivers the drug without
disrupting the skin barrier and has been shown to be safe and
tolerable. ZORYVE foam is thus ideally formulated, having the
potential to become the new standard of care for seborrheic
dermatitis treatment,” said Andrew Blauvelt, MD, MBA, clinical
investigator at Oregon Medical Research Center, and investigator on
the STRATUM trial.
Beyond the appearance and irritation of physical symptoms,
seborrheic dermatitis is associated with a decrease in quality of
life and may negatively affect emotional well-being, self-esteem,
and day-to-day life, including sleep and work. People with
seborrheic dermatitis, and especially adolescents and school-age
children, may suffer from social stigma, negative self-image, and
low self-esteem associated with very visible skin diseases like
seborrheic dermatitis.
“Approximately 10 million people in the United States have
seborrheic dermatitis, but until today, there have been limited
treatment options. We are thrilled with this FDA approval and are
excited to bring to market a new, highly effective steroid-free
topical formulation that can be used anywhere on the body,” said
Frank Watanabe, president and CEO of Arcutis. “Our commercial team
is ready and poised to launch ZORYVE foam very soon, and we are
committed to ensuring affordable access to ZORYVE foam to those who
may benefit from this novel treatment.”
Arcutis intends to make ZORYVE foam widely available via key
wholesaler and dermatology pharmacy channels as a new treatment
option by the end of January 2024. The Company is dedicated to
responsible pricing and affordable access to therapy. The ZORYVE®
Direct Program helps patients access their prescribed Arcutis
medication. For patients with seborrheic dermatitis who have been
prescribed ZORYVE, this patient support program helps patients
navigate the payer process, assists patients with adherence, and
includes the ZORYVE Direct Savings Card Program, which can help
reduce out-of-pocket costs for eligible commercially insured
patients.† Arcutis will also continue to offer the Arcutis CaresTM
patient assistance program (PAP) that provides ZORYVE at no cost
for financially eligible patients who are uninsured or
underinsured.‡
Management will host a conference call on Monday, December 18 at
8:30 a.m. EST. A live webcast of the call and presentation material
will be available on the “Events” section of the Company's Investor
website. An archived version of the webcast will be available on
the Arcutis website after the call.
ZORYVE Foam Clinical Data The approval is
supported by positive results from Arcutis’ Phase 2 and
pivotal Phase 3 trials in seborrheic dermatitis. The STudy
of Roflumilast foam Applied Topically for the
redUction of seborrheic derMatitis (STRATUM) and the Phase
2 (Trial 203) were parallel group, double-blind,
vehicle-controlled studies evaluating the safety and efficacy of
ZORYVE foam 0.3% in seborrheic dermatitis. Together the two
studies enrolled 683 adults and adolescents ages 9 years and
older.
The STRATUM study met its primary endpoint, with nearly 80% of
ZORYVE foam treated individuals reaching Investigator Global
Assessment (IGA) Success rate at Week 8 (79.5% ZORYVE foam vs 58.0%
vehicle; P<0.0001). In Trial 203, 73% of individuals treated
with ZORYVE foam achieved IGA Success (73.1% ZORYVE foam vs 40.8%
vehicle; P<0.0001.) IGA Success was defined as an IGA score of
“Clear” (0) or “Almost Clear” (1), plus a 2-grade IGA score
improvement from baseline at Week 8.
Improvement with ZORYVE foam was seen early, with roflumilast
demonstrating a statistically significant improvement compared to
vehicle on IGA Success at Week 2, the first timepoint assessed in
STRATUM. In addition, 50.6% of individuals in the ZORYVE foam
treated arm reached complete clearance (IGA=0) at Week 8.
The STRATUM study also demonstrated statistically significant
improvement over vehicle on all secondary endpoints, including
itch, scaling, and erythema (redness). More than 60% of individuals
achieved a ≥4-point reduction in itch at Week 8 as measured by
Worst Itch-Numerical Rating Score (62.8% roflumilast foam vs 40.6%
vehicle; P=0.0001), and significant improvements in itch were also
reported at Week 2 and Week 4. Individuals treated with ZORYVE foam
reported a 28% improvement in itch from baseline in 48 hours
(compared to 13% on vehicle nominal P=0.0024).
In addition, more than 50% of individuals treated with ZORYVE
foam achieved an erythema (redness) score of 0, and more than 50%
achieved a scaling score of 0, at Week 8. Treatment with ZORYVE
foam demonstrated a significantly larger improvement in patient
reported outcomes as early as Week 2 as measured through
Dermatology Life Quality Index (DLQI), with improvements maintained
through Week 8.ZORYVE foam was well-tolerated with a favorable
safety and tolerability profile during up to 52 weeks of treatment.
Incidence of Treatment Emergent Adverse Events (TEAEs) was low and
similar between active treatment and vehicle, with most TEAEs
assessed as mild to moderate severity. There were no
treatment-related Serious Adverse Events (SAEs). Overall, the most
common adverse reactions occurring in ≥1% of subjects in the
combined Phase 2 and Phase 3 study populations were nasopharyngitis
(1.5%), nausea (1.3%), and headache (1.1%).
A Media Snippet accompanying this announcement is available by
clicking on this link.
About ZORYVE®ZORYVE
(roflumilast) topical foam, 0.3%, is indicated for treatment of
seborrheic dermatitis in adult and pediatric patients 9 years of
age and older. Another formulation of ZORYVE, roflumilast cream
0.3%, is approved by the FDA for the topical treatment of plaque
psoriasis in individuals 6 years of age and older. Both ZORYVE foam
and cream are topical formulations of roflumilast, a highly potent
and selective phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an
intracellular enzyme that increases the production of
pro-inflammatory mediators and decreases production of
anti-inflammatory mediators. It is an established target in
dermatology.
INDICATIONSZORYVE cream is indicated for
topical treatment of plaque psoriasis, including intertriginous
areas, in patients 6 years of age and older.
ZORYVE foam, 0.3%, is indicated for treatment of seborrheic
dermatitis in adult and pediatric patients 9 years of age and
older.
IMPORTANT SAFETY INFORMATION ZORYVE is
contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are flammable.
Avoid fire, flame, and smoking during and immediately following
application.
The most common adverse reactions (≥1%) for ZORYVE cream 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 foam include
nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Please see full Prescribing Information for ZORYVE foam and full
Prescribing Information for ZORYVE cream.
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 of ZORYVE foam to
simplify disease management for care of seborrheic dermatitis,
potential of ZORYVE foam to become the standard of care in
seborrheic dermatitis treatment, and the Company’s expected timing
and plan to commercially launch ZORYVE foam by end of January.
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 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.
† Subject to eligibility criteria and maximum
program limitation. This offer is not valid for patients without
commercial drug insurance or whose prescription claims are eligible
to be reimbursed, in whole or in part, by any government
program.
‡ Subject to financial eligibility requirements. Other terms and
restrictions apply.
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com
Investors
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
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