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Dermavant
Announces Approval of
Tapinarof
in both
Psoriasis
and
Atopic Dermatitis
in Japan
2024-06-25
·
交易
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BioSpace
临床3期
上市批准
引进/卖出
临床结果
免疫疗法
- In 2020,
Dermavant
licensed Japan rights to
Japan Tobacco
to develop and commercialize
tapinarof
for
psoriasis
and
atopic dermatitis
- -
Dermavant
to receive milestone payment of $28 million in connection with approval in Japan - -
VTAMA
® (
tapinarof
) cream, 1% is approved in the U.S. for the treatment of
plaque psoriasis
in adults - -
Dermavant
recently filed an sNDA in the U.S for the treatment of
atopic dermatitis
in adults and children two years of age and older, with a PDUFA date in Q4 2024 - LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--
Dermavant Sciences Inc.
, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that
Japan Tobacco
has received approval in Japan for tapinarof cream, 1% for the treatment of both adults with psoriasis and patients 12 years of age and older with atopic dermatitis. “I believe
Japan Tobacco
’s approval speaks to
tapinarof
’s unique proposition in Japan as a once-daily, cosmetically elegant and
steroid
-free, topical cream for both acute treatment and long-term management of
psoriasis
and
atopic dermatitis
and we applaud our partner’s success,” said Todd Zavodnick, Chief Executive Officer of
Dermavant
. “Our commitment to bringing VTAMA (tapinarof) cream, 1% to as many U.S. patients as we can remains resolute. We are currently focused on preparing for the commercial launch of
VTAMA cream
, subject to
FDA
approval, for its second U.S. indication of
atopic dermatitis
, and look forward to the PDUFA date for our Supplemental New Drug Application in Q4 2024.” Under the terms of the 2020 license agreement,
Dermavant
received an upfront payment of $60 million, with up to a further $53 million payable upon the achievement of certain development milestones for
tapinarof
for the treatment of
psoriasis
and
atopic dermatitis
including $28 million for approval in Japan. In addition,
Dermavant
has the right to receive royalties based on product sales of
tapinarof
in Japan.
VTAMA cream
, 1% is a novel,
aryl hydrocarbon receptor agonist
aryl hydrocarbon receptor
agonist in development in the U.S. as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of
atopic dermatitis (AD)
.
VTAMA cream
, 1% is currently approved for the topical treatment of
plaque psoriasis
in adults in the U.S. In April 2024, the
U.S. Food and Drug Administration (FDA)
accepted the company’s sNDA for
VTAMA
® (
tapinarof
) cream, 1% for the topical treatment of AD in adults and children 2 years of age and older. The Prescription Drug User Fee Act (“PDUFA”) action date assigned by the Agency is in Q4 2024. IMPORTANT SAFETY INFORMATION Indication:
VTAMA
® (
tapinarof
) cream, 1% is an
aryl hydrocarbon receptor agonist
aryl hydrocarbon receptor
agonist indicated for the topical treatment of
plaque psoriasis
in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with
VTAMA cream
were
folliculitis
(red raised bumps around the hair pores),
nasopharyngitis
(
pain
or
swelling
in the nose and throat),
contact dermatitis
(
skin rash
or irritation, including
itching
and redness, peeling, burning, or stinging),
headache
,
pruritus
(itching)
, and
influenza
(flu)
. You are encouraged to report negative side effects of prescription drugs to the
FDA
. Visit or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. About
Dermavant
’s Phase 3 Program for
VTAMA cream
in
Atopic Dermatitis ADORING
is
Dermavant
’s Phase 3
atopic dermatitis (AD)
clinical development program for
VTAMA
® (
tapinarof
) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, extension trial. About
Atopic Dermatitis
Atopic dermatitis (AD)
, commonly referred to as
eczema
, is one of the most common
inflammatory skin diseases
, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck.
Itching
is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing
fatigue
, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease. About
Dermavant
Dermavant Sciences
, a subsidiary of
Roivant Sciences
, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology.
Dermavant
’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets,
plaque psoriasis
and
atopic dermatitis
, as well as other
immunological and inflammatory diseases
.
Dermavant
is marketing
VTAMA
® (
tapinarof
) cream, 1%, for the topical treatment of
plaque psoriasis
in adults. The
FDA
approved
VTAMA cream
for the topical treatment of mild, moderate, and severe
plaque psoriasis
in May 2022.
Dermavant
has been developing
VTAMA cream
for the treatment of
atopic dermatitis
in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023.
Dermavant
’s pipeline includes
DMVT-506
, a next generation
aryl hydrocarbon receptor (AhR)
agonist under development as a potential treatment option for
immunological and inflammatory diseases
with multiple potential routes of administration. For more information, please visit and follow us on Twitter (@dermavant) and LinkedIn (
Dermavant Sciences
). ©2024
Dermavant Sciences, Inc.
All Rights Reserved. All trademarks are the property of
Dermavant Sciences, GmbH
.
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机构
Dermavant Sciences, Inc.
Japan Tobacco, Inc.
Dermavant Sciences GmbH
[+2]
适应症
银屑病
特应性皮炎
斑块状银屑病
[+13]
靶点
AHR
药物
本维莫德
ORIL-003
SM-350300
[+1]
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