Dupixent® (dupilumab) showed positive
topline results in Phase 3 trial of children aged 6 to 11 years
with severe atopic dermatitis
- U.S. FDA submission for children planned for 4Q 2019
PARIS and TARRYTOWN, NY – August 6,
2019 – A pivotal Phase 3 trial evaluating Dupixent®
(dupilumab) to treat severe atopic dermatitis in children aged 6 to
11 years met its primary and secondary endpoints. Dupixent is the
first and only biologic to show positive results in this pediatric
atopic dermatitis population.
The topline data show that for children with
severe atopic dermatitis (covering nearly 60% of their skin surface
on average), adding Dupixent to standard-of-care topical
corticosteroids (TCS) significantly improved measures of overall
disease severity, skin clearing, itching and health-related quality
of life, compared to TCS alone. In addition, the safety data were
consistent with the previously documented safety profile of
Dupixent in older populations, including a numerically lower rate
of skin infections compared to
placebo.
“The results from this trial, the first to assess a biologic
medicine in children under 12 with atopic dermatitis, are very
important because of the significant unmet needs in this patient
population. Children in the trial had suffered from severe atopic
dermatitis for most of their lives,” said George D. Yancopoulos,
M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
“The trial showed that Dupixent significantly improved outcomes and
quality of life, with no new safety signals.
Dupixent is a fully-human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials
have shown that IL-4 and IL-13 are key drivers of the type 2
inflammation that plays a major role in atopic dermatitis, asthma
and chronic rhinosinusitis with nasal polyposis (CRSwNP).
“In this trial, children with severe atopic
dermatitis had uncontrolled disease covering, on average, nearly
60% of their skin. The unrelenting symptoms of this disease, which
impact not just the child but the whole family,
include widespread rashes, intense and persistent itching, and
skin lesions,” said John Reed, M.D., Ph.D., Global Head of
Research and Development at Sanofi. "Symptoms of severe atopic
dermatitis can take a toll on children both physically and
emotionally. We are encouraged by these results, which demonstrate
that Dupixent improved skin lesions, reduced itching,
cleared the skin and importantly, improved health-related quality
of life measures for these young patients.”
The primary endpoints assessed the proportion of
patients achieving an Investigator's Global Assessment (IGA) score
of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area
and Severity Index (EASI-75, the co-primary endpoint outside of the
U.S.) at 16 weeks.
Results at 16 weeks included:
- 33% of patients who received Dupixent every four weeks (300 mg)
and 30% of patients who received Dupixent every two weeks (100 mg
or 200 mg, based on weight) achieved clear or almost clear skin
(IGA; score of 0 or 1), compared to 11% for placebo (p<0.0001
and p=0.0004, respectively).
- 70% of patients who received Dupixent every four weeks and 67%
of patients who received Dupixent every two weeks achieved 75% or
greater skin improvement (EASI-75), compared to 27% for placebo
(p<0.0001 for both).
- The average EASI score improvement from baseline was 82% in the
Dupixent every four weeks group and 78% in the Dupixent every two
weeks group, compared to 49% for placebo (p<0.0001 for
both).
- Dupixent demonstrated significant itch relief, and also
improved measures of patient-reported outcomes, such as anxiety,
depression and health-related quality of life of parents and family
members.
For the 16-week treatment period, the overall
rates of adverse events were 65% for Dupixent every four weeks, 67%
for Dupixent every two weeks and 73% for placebo. Adverse
events that were more commonly observed with Dupixent included
conjunctivitis (7% for Dupixent every four weeks, 15% for Dupixent
every two weeks and 4% for placebo), nasopharyngitis (13% for
Dupixent every four weeks, 7% for Dupixent every two weeks and 7%
placebo) and injection site reactions (10% for Dupixent every four
weeks, 11% for Dupixent every two weeks and 6% for placebo).
Additional prespecified adverse events included skin infections (6%
for Dupixent every four weeks, 8% for Dupixent every two weeks and
13% for placebo) and herpes viral infections (2% for Dupixent every
four weeks, 3% for Dupixent every two weeks and 5% for
placebo).
Detailed results from this trial will be
presented at a future medical meeting and data will be submitted to
regulatory authorities, starting with the U.S. Food and Drug
Administration (FDA) in 4Q 2019. In 2016, the FDA granted
Breakthrough Therapy designation for Dupixent for the treatment of
moderate-to-severe (12 to 17 years of age) and severe (6 months to
11 years of age) atopic dermatitis. The efficacy and safety of
Dupixent in children below the age of 12 has not been reviewed by
any regulatory authority.
About the Dupixent Pediatric
Trial The Phase 3, randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent combined with TCS in children with severe atopic
dermatitis. The trial enrolled 367 patients aged 6 to 11 years with
severe atopic dermatitis whose disease could not be adequately
controlled with topical medications. In total, 92% of these
patients suffered from at least one concurrent condition such as
allergic rhinitis, asthma and food allergy.
All patients received TCS throughout the trial.
Patients were randomized into one of three treatment groups for the
16-week treatment period: Dupixent subcutaneous injection 300 mg
every four weeks (with an initial dose of 600 mg); Dupixent 100 mg
or 200 mg every two weeks, based on weight (100 mg for <30 kg,
200 mg for ³30 kg), with an initial dose of 200 mg or 400 mg,
respectively; and placebo every two or four weeks.
Dupilumab Development ProgramIn
addition to the currently approved indications, Sanofi and
Regeneron are also studying dupilumab in a broad range of clinical
development programs for diseases driven by allergic and other type
2 inflammation, including pediatric asthma and atopic dermatitis (6
to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months
to 5 years of age, Phase 2/3), eosinophilic esophagitis (Phase
2/3), chronic obstructive pulmonary disease (Phase 3) and food and
environmental allergies (Phase 2). Dupilumab is also being studied
in combination with REGN3500 (SAR440340), which targets IL-33.
These potential uses are investigational and the safety and
efficacy have not been evaluated by any regulatory authority.
Dupilumab is being jointly developed by Sanofi
and Regeneron under global collaboration agreement.
About Regeneron Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for 30 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to seven FDA-approved treatments and numerous
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye disease, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, infectious diseases,
pain and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune® which produces
optimized fully-human antibodies, and ambitious research
initiatives such as the Regeneron Genetics Center, which is
conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company,
please visit www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi Sanofi is dedicated to
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illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
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Regeneron Media Relations ContactSharon ChenTel.:
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