ZORYVE® (roflumilast) Topical Foam, 0.3%, for the Treatment of Seborrheic Dermatitis Launches in the United States
22 Janeiro 2024 - 10:00AM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced the
launch of ZORYVE® (roflumilast) topical foam, 0.3%, in the United
States for the treatment of seborrheic dermatitis in individuals 9
years of age and older. ZORYVE is a once-daily steroid-free foam
and is the first drug approved for seborrheic dermatitis with a new
mechanism of action in over two decades.
“Despite being a very common condition with significant negative
impact on quality of life, seborrheic dermatitis has largely been
overlooked by the pharmaceutical industry,” said Todd Edwards,
chief commercial officer at Arcutis. “We are proud to launch our
second commercial product in the United States and have it
immediately available in pharmacies with strong reimbursement from
the major pharmacy benefit managers through our already established
contracts.”
“Following decades without significant innovation in seborrheic
dermatitis treatment, it’s exciting to have an approved, targeted
treatment option for such a common yet burdensome inflammatory
disease. ZORYVE foam possesses several unique qualities that
address unmet needs of seborrheic dermatitis patients. Notably,
ZORYVE foam offers once-daily application, a water-based foam
vehicle that can be used anywhere on the body, and versatility for
use across all skin and hair types as well as the full spectrum of
disease severity,” said Raj Chovatiya, MD, PhD, MSCI, a
board-certified dermatologist and clinical investigator based in
Chicago. “In clinical trials, ZORYVE foam provided complete
clearance for more than half of all subjects, and 3 in 4 patients
achieved IGA treatment success at 8 weeks, with greater than 40%
achieving IGA treatment success as early as two weeks. Based on
these key attributes, ZORYVE foam has the potential to define a new
standard of care for seborrheic dermatitis.”
ZORYVE foam will be available via wholesaler and pharmacy
channels this week. ZORYVE foam is listed as a line extension
within key commercial PBM contracts, which will provide the
opportunity for rapid formulary access.
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.‡
On December 15, 2023, Arcutis announced that the U.S. Food and
Drug Administration (FDA) had approved ZORYVE foam for the
treatment of seborrheic dermatitis in individuals 9 years of age
and older.
Management will host a conference call on Monday, January 22 at
1:30 pm PST/4:30 pm 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.
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 two 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, atopic dermatitis, and alopecia areata. For more
information, visit www.arcutis.com or follow Arcutis on
LinkedIn, Facebook, and X.
INDICATIONZORYVE 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%) include nasopharyngitis
(1.5%), nausea (1.3%), and headache (1.1%).
Please see full Prescribing Information.
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 commercial launch of
ZORYVE foam in seborrheic dermatitis, including product
availability and access. 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
InvestorsDerek ColeInvestor Relations Advisory
Solutionsderek.cole@iradvisory.com
† Uninsured patients and patients with government insurance are
not eligible for the ZORYVE Direct savings program. Other terms and
restrictions apply
‡ Subject to financial eligibility requirements. Other terms and
restrictions apply
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