生物医药系列产品
数据
资源
版本对比
免费注册
预约演示
免费注册
Dermavant
Announces
FDA
Acceptance of Supplemental New Drug Application (sNDA) for
VTAMA
® (
tapinarof
) Cream, 1% for the Treatment of
Atopic Dermatitis
in Adults and Children 2 Years of Age and Older
2024-04-29
·
BioSpace
临床3期
临床结果
上市批准
免疫疗法
- sNDA filing acceptance is based on positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the Phase 3 ADORING 3 open-label, long-term extension trial- -
FDA
PDUFA Action Expected 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 the
U.S. Food and Drug Administration (FDA)
accepted the company’s Supplemental New Drug Application (sNDA) for
VTAMA
® (
tapinarof
) cream, 1% for the topical treatment of
atopic dermatitis (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.
VTAMA cream
is a novel,
aryl hydrocarbon receptor agonist
aryl hydrocarbon receptor
agonist in development as a once-daily, cosmetically elegant, and
steroid
-free, topical cream for both acute treatment and long-term management of AD.
VTAMA cream
, 1% is currently approved for the topical treatment of
plaque psoriasis
in adults in the U.S. and is the same strength and formulation being studied in the ADORING Phase 3 development program and included in the sNDA submission for AD.
Atopic dermatitis
, commonly referred to as
eczema
, is one of the most common
inflammatory skin diseases
that causes
inflammation
, intense
itch
, redness, and irritation of skin and impacts approximately 16.5 million adults and more than 9.6 million children in the U.S. Approximately 80% of individuals affected by
atopic dermatitis
experience disease onset prior to 6 years of age; if approved
VTAMA cream
may be available for children as young as 2 years old affected with
atopic dermatitis
. “The
FDA
acceptance of our sNDA is an important milestone in our efforts to bring
VTAMA cream
, as a potentially safe and well-tolerated non-steroidal treatment option, to adults and children as young as 2 years old who suffer from
atopic dermatitis
,” said Todd Zavodnick, Chief Executive Officer of
Dermavant
. “Our commitment to patients is unwavering, and we remain highly focused on preparing for the commercial launch of
VTAMA cream
, subject to
FDA
approval, for its second indication of
atopic dermatitis
.” The regulatory application is supported by positive Phase 3 data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled, pivotal trials, as well as an open-label maximal usage pharmacokinetics (MUPK) trial in children aged 2-17 years, and the interim analysis results of ADORING 3, a Phase 3, 48-week, open-label, extension trial. On May 24, 2022,
Dermavant
announced the
FDA
approved
VTAMA
® (
tapinarof
) cream, 1% for the treatment of
plaque psoriasis
in adults. The approval made
VTAMA cream
the first non-steroidal topical novel chemical entity launched for
psoriasis
in the U.S. in more than 25 years.
VTAMA cream
is once-daily, cosmetically elegant, steroid-free, topical cream approved for mild, moderate, and severe
plaque psoriasis
in adults – with no label safety warnings or precautions, or restrictions on duration of use or body surface area. 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
.
更多内容,
请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点,如有版权侵扰或错误之处,请及时联系我们,我们会在24小时内配合处理。
机构
Dermavant Sciences GmbH
US Food & Drug Administration
Dermavant Sciences, Inc.
[+1]
适应症
特应性皮炎
斑块状银屑病
湿疹
[+13]
靶点
AHR
药物
本维莫德
SM-350300
ORIL-003
[+1]
标准版
¥
16800
元/账号/年
新药情报库 | 省钱又好用!
立即使用
来和芽仔聊天吧
热门报告
特应性皮炎深度解析:药物开发、专利分析与风险评估
智慧芽生物医药
2024年7月全球首批及特殊审评药物报告
智慧芽生物医药
GPRC5D靶点专利调研报告
智慧芽生物医药
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台,助您全方位提升您的研发与决策效率。
开始免费试用
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台,以API或者数据包形式对外开放,助您更加充分利用智慧芽新药情报信息。
试用数据服务