- EFFICACY: In the pivotal studies, ADORING 1 and ADORING 2, up
to 46% of patients on VTAMA cream achieved vIGA-AD™ treatment
success at Week 8 versus 18% of patients on vehicle.
- POWERFUL SKIN CLEARANCE: The majority of patients entered with
or achieved complete disease clearance (vIGA-AD=0) at least once in
the 48-week open-label ADORING long-term extension (LTE) study and
remained treatment-free (remittive effect) for an average of ~80
consecutive days.
- RAPID ITCH RELIEF: Itch improvement as early as 24 hours after
first application of VTAMA cream was reported by patients and
caregivers.
- SAFE AND TOLERABLE: VTAMA cream demonstrated a favorable and
consistent safety profile in both the 8-week pivotal studies and
the 48-week long-term extension (LTE) study; and was
well-tolerated, including on affected sensitive skin areas.
Organon (NYSE: OGN), a global healthcare company with a mission
to improve the health of women throughout their lives, today
announced that the U.S. Food and Drug Administration (FDA) has
approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor
agonist, for an additional indication of the topical treatment of
atopic dermatitis (AD) in adults and pediatric patients 2 years of
age and older.1 Organon received the FDA approval prior to its
extended target action date (PDUFA) of March 12, 2025.
“With the FDA’s approval of VTAMA cream in atopic dermatitis for
adults and children as young as 2 years old, there is now a therapy
that offers the potential for powerful skin clearance with no label
warnings or precautions, contraindications, and no restrictions on
duration of use or percentage of body surface area affected,” said
Kevin Ali, Organon’s Chief Executive Officer. “Introducing this new
first-in-class therapy for AD patients reaffirms Organon’s
commitment to addressing areas of high unmet need.”
In the ADORING pivotal studies, VTAMA cream, 1% demonstrated, in
moderate to severe patients as young as 2 years old with AD, a
statistically significant difference versus vehicle in the
proportion of patients achieving a score of clear (0) or almost
clear (1) and a minimum 2-grade improvement from baseline at Week 8
on the Validated Investigator Global Assessment for AD (vIGA-AD)
45.4% versus 13.9% of patients in ADORING 1 and 46.4% versus 18.0%
in ADORING 2 (both P<0.0001). The difference between patients
who received VTAMA cream and those that received vehicle in all
secondary endpoints was statistically significant, including the
Eczema Area and Severity Index (EASI) score improvement of at least
75% (EASI75) from baseline at Week 8 and achievement of a ≥4-point
improvement in the patients reported Peak Pruritus Numerical Rating
Scale (PP-NRS) from baseline at Week 8 in patients ≥12 years of
age. The most common adverse reactions (incidence ≥1%) were upper
respiratory tract infection (12%), red raised bumps around the hair
pores (folliculitis) (9%), lower respiratory tract infection (5%),
headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain
in extremity (2%), and stomach-area (abdominal) pain (1%).
ADORING 3, a 48-week open-label, LTE study, enrolled eligible
patients from ADORING 1, ADORING 2, a 4-week maximal usage
pharmacokinetics trial, and direct enrollees who were VTAMA
cream-naive patients 2-17 years of age with mild, moderate or
severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did
not meet pivotal studies inclusion criteria.
In ADORING 3, patients (N=728) were followed for up to 48 weeks,
with safety and efficacy endpoints that included the achievement of
complete disease clearance (vIGA-AD=0), and the achievement of
clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with
any disease activity (vIGA-AD≥1) were treated with VTAMA cream, 1%
until complete disease clearance was achieved (vIGA-AD=0) or study
completion. For the 378 patients who entered with or achieved
complete disease clearance (vIGA-AD=0) in ADORING 3 and
discontinued treatment with VTAMA cream, the mean duration of the
first treatment-free (remittive) interval was approximately 80
consecutive days. Patients whose AD returned to mild or above
(vIGA-AD≥2) were re-treated with VTAMA cream until complete disease
clearance was achieved again or study completion. The safety
profile with long term use was generally consistent with the safety
profile observed at Week 8.
“VTAMA cream approval in AD is important because it can be
prescribed for children as young as 2 years old. VTAMA cream has
the potential to bring much needed relief to a significant number
of children suffering from this disease,” said Adelaide A. Hebert,
MD, Professor and Chief of Pediatric Dermatology at McGovern
Medical School at UTHealth Houston and Children’s Memorial Hermann
Hospital and lead investigator for the ADORING program. “Moreover,
because the prevalence of itch makes this condition extremely
burdensome to patients and their families, the itch data from the
ADORING program demonstrates reduction of one of the condition’s
most prevalent symptoms with use of VTAMA cream.”
In May 2022, the FDA approved VTAMA® (tapinarof) cream, 1% for
the treatment of plaque psoriasis in adults, making it the first
non-steroidal topical novel chemical entity launched for plaque
psoriasis in the U.S. in more than 25 years. VTAMA cream is
approved for mild, moderate, and severe plaque psoriasis with no
label warnings or precautions, contraindications, restrictions on
duration of use, or percentage of body surface area affected.
For more information about VTAMA (tapinarof) cream, 1%, visit
www.VTAMA.com.
IMPORTANT SAFETY INFORMATION
Indications: VTAMA® (tapinarof) cream, 1% is an aryl
hydrocarbon receptor agonist indicated for:
- the topical treatment of plaque psoriasis in adults.
- the topical treatment of atopic dermatitis in adults and
pediatric patients 2 years of age and older.
Adverse Events: In plaque psoriasis, the most common
adverse reactions (incidence ≥1%) were: red raised bumps around the
hair pores (folliculitis); pain or swelling in the nose and throat
(nasopharyngitis); skin rash or irritation, including itching and
redness, peeling, burning, or stinging (contact dermatitis);
headache; itching (pruritus); and flu (influenza).
Adverse Events: In atopic dermatitis, the most common
adverse reactions (incidence ≥1%) were: upper respiratory tract
infection; red raised bumps around the hair pores (folliculitis);
lower respiratory tract infection; headache; asthma; vomiting; ear
infection; pain in extremity; and stomach-area (abdominal)
pain.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
See full Prescribing Information and Patient Information.
About Atopic Dermatitis
Atopic dermatitis (AD), commonly referred to as eczema, is one
of the most prevalent inflammatory skin diseases, affecting 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 on the folds of the arms, back of the knees, hands,
face, and neck. Itching is an especially bothersome symptom for
those with 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 Organon
Organon is an independent global healthcare company with a
mission to help improve the health of women throughout their lives.
Organon’s diverse portfolio offers more than 60 medicines and
products in women’s health, biosimilars, and a large franchise of
established medicines across a range of therapeutic areas. In
addition to Organon’s current products, the company invests in
innovative solutions and research to drive future growth
opportunities in women’s health and biosimilars. Organon is also
pursuing opportunities to collaborate with biopharmaceutical
partners and innovators who look to commercialize their products by
leveraging Organon’s scale and agile presence in fast growing
international markets.
Organon has geographic scope with significant reach, world-class
commercial capabilities, and approximately 10,000 employees with
headquarters located in Jersey City, New Jersey.
For more information, visit http://www.organon.com and connect
with us on LinkedIn, Instagram, X (formerly known as Twitter) and
Facebook.
vIGA-AD is the trademark of Eli Lilly and Co.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including, but not limited to, statements about management’s
expectations about the potential safety, effectiveness,
tolerability, uses, and market for VTAMA cream. Forward-looking
statements may be identified by words such as “pursuing,”
“opportunities,” “future,” “potential,” “potentially,” “expected,”
“expects,” “will” or words of similar meaning. These statements are
based upon the current beliefs and expectations of Organon’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or additional risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Risks and
uncertainties include, but are not limited to, an inability to
execute on our business development strategy or realize the
benefits of the FDA approval described above; weakening of economic
conditions that could adversely affect the level of demand for
VTAMA; pricing pressures globally, including rules and practices of
managed care groups, judicial decisions and governmental laws and
regulations related to Medicare, Medicaid and health care reform,
pharmaceutical reimbursement and pricing in general; an inability
to fully execute on Organon’s product development and
commercialization plans; an inability to adapt to the industry-wide
trend toward highly discounted channels; expanded brand and class
competition in the markets in which Organon operates; and
governmental initiatives that adversely impact Organon’s marketing
activities. Organon undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Organon’s filings with
the Securities and Exchange Commission (SEC), including Organon’s
most recent Annual Report on Form 10-K and subsequent SEC filings,
available at the SEC’s Internet site www.sec.gov. References and
links to websites have been provided for convenience, and the
information contained on any such website is not a part of, or
incorporated by reference into, this press release. Organon is not
responsible for the contents of third-party websites.
1 VTAMA label.
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Media Contacts:
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Investor Contacts:
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Organon (NYSE:OGN)
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