Arcutis Biotherapeutics, Inc. an early
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, announced the
U.S. Food and Drug Administration (FDA) approval of the the New Drug
Application (NDA) for Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis,
including intertriginous areas, in patients 12 years of age or older.
The first and only topical phosphodiesterase-4 (PDE4) inhibitor approved
for the treatment of plaque psoriasis, Zoryve provides rapid clearance
of psoriasis plaques and reduces itch in all affected areas of the body.
Zoryve — a once-daily, steroid-free cream in a safe and well tolerated,
patient-friendly formulation — is uniquely formulated to simplify
disease management for people living with plaque psoriasis.
“Today Arcutis has reached a major milestone, with our ability to
offer this next generation topical PDE4 inhibitor to both adults and
adolescents with plaque psoriasis. Zoryve’s combination of efficacy,
safety, and tolerability, coupled with our proprietary HydroARQ
Technology formulation, is designed to fit into patients’ everyday lives
with no restrictions on duration of use,” said Frank Watanabe,
President and CEO of Arcutis. “Additionally, Zoryve has been shown to
rapidly clear plaques and reduce itch across all areas of the body.
Zoryve is the only topical for which data focused on the treatment of
intertriginous plaques — a common area affected by plaque psoriasis —
have been specifically generated. This FDA approval is the fruition of
our efforts, and we are excited to launch Zoryve, with expected product
availability by mid-August.”
Topical therapies remain the primary treatment option for the vast
majority of individuals with plaque psoriasis, a common immune-mediated
skin disease that affects approximately nine million people in the U.S.
and is the most frequent type of psoriasis occurring in both adults and
adolescents. Severity can range between mild, moderate, and severe, with
itch being the most burdensome and frequently reported symptom.
While the disease may affect any area of the body, plaques in certain
areas, like the face, elbows and knees, genitalia, and intertriginous
areas (areas of skin-to-skin contact), present unique treatment
challenges. As a result, individuals with psoriasis are often prescribed
multiple topical medications for different areas, which makes for a
complicated treatment regimen.
“In multiple clinical trials, Zoryve was proven to be safe and
effective, with improvements in disease clearance in hard-to-treat areas
like knees and elbows, as well as in sensitive areas such as the face,
genitalia, and intertriginous areas. Zoryve is very well tolerated,
which is an important consideration for treating a chronic skin disease
such as plaque psoriasis,” said Mark Lebwohl M.D., FAAD, principal
investigator and Dean for Clinical Therapeutics and Chairman Emeritus of
the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn
School of Medicine at Mount Sinai. “With this FDA approval, adults and
adolescents with psoriasis and their dermatologists have a new
steroid-free treatment option for use on all affected areas of the
body.”
Zoryve features HydroARQ Technology™, a proprietary drug delivery
formulation that creates a non-greasy moisturizing cream that spreads
easily and absorbs quickly.
“Plaque psoriasis is a challenging disease and finding the right
treatment option can be complicated, especially if individuals have to
use multiple treatments for different parts of their body. We welcome a
new treatment option that can make a meaningful difference for adults
and adolescents with plaque psoriasis,” says Leah M. Howard, President
and CEO of the National Psoriasis Foundation. “Our hope is that new
treatments translate into improved outcomes and help alleviate the
burdens of chronic disease for people impacted by psoriasis.”
Arcutis intends to make Zoryve widely available via key wholesaler
and national dermatology pharmacy channels as a new treatment option by
mid-August, and the Company is dedicated to affordable access to
therapy. The Zoryve Direct patient support program will help
commercially insured individuals with plaque psoriasis get access and
start Zoryve treatment as prescribed by their healthcare provider
quickly and easily by helping them navigate the payer process, lowering
the out-of-pocket cost for eligible patients, and offering programs that
support staying on therapy.† Arcutis will also offer the
Arcutis Cares patient assistance program (PAP) – the first of its kind
for a topical psoriasis treatment – that will provide Zoryve at no cost
for financially eligible patients who are uninsured or underinsured.‡
With this approval, Arcutis has access to, and plans to draw, an
additional $125 million tranche as part of the Company’s non-dilutive
financing agreement with SLR Capital Partners. Combined with the
Company’s cash, cash equivalents, restricted cash, and marketable
securities as of June 30, 2022, this additional $125 million will
provide for capital resources of over $400 million to support the launch
and commercialization efforts for Zoryve, as well as continue to
advance the Company’s pipeline development initiatives.
Ref : https://en.wikipedia.org/wiki/Roflumilast
