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Press ReleaseSource: Sanofi (EURONEXT: SAN)
(NYSE: SNY) |
Dupixent® (dupilumab) showed positive Phase 3 results in
adolescents with inadequately controlled moderate-to-severe atopic
dermatitis U.S. regulatory submission for patients ages 12-17
planned for third quarter 2018 Paris and Tarrytown, NY - May 16,
2018 - A pivotal Phase 3 trial evaluating Dupixent® (dupilumab)
to treat moderate-to-severe atopic dermatitis in adolescents (ages
12-17) met its primary and key secondary endpoints. In the trial,
treatment with Dupixent as monotherapy significantly improved
measures of overall disease severity, skin clearing, itching, and
certain health-related quality of life measures. Dupixent is the
first and only biologic to show positive results in this patient
population. "Moderate-to-severe atopic dermatitis can place a
particularly significant burden on adolescents, who have to deal
with oozing skin lesions with unrelenting, intense itching during
their formative years," said George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer of Regeneron. "Dupixent
blocks the IL-4/IL-13 pathway, which is emerging as a central
driver of Type 2 allergic inflammation. We are committed to
investigating the potential for Dupixent across Type 2 inflammatory
diseases with high unmet need including atopic dermatitis, asthma,
eosinophilic esophagitis, nasal polyps, chronic obstructive
pulmonary disease, and food allergy." Patients treated with
Dupixent had significant improvement in disease severity at 16
weeks The primary endpoints were the proportion of patients
achieving Investigator's Global Assessment (IGA) score of 0 (clear)
or 1 (almost clear) and 75% improvement in Eczema Area and Severity
Index (EASI-75, co-primary endpoint outside of the U.S.) at 16
weeks. Results included: 24% of patients who received weight-based
dosing of Dupixent every two weeks (200 mg or 300 mg) and 18% of
patients who received a fixed dose of Dupixent every four weeks
(300 mg) achieved the primary endpoint - clear or almost-clear skin
(IGA; score of 0 or 1) - compared with 2% with placebo (p less than
0.0001, and p= 0.0007, respectively). 41.5% of patients who
received Dupixent every two weeks and 38% of patients who received
Dupixent every four weeks achieved 75% or greater skin improvement
(EASI-75) compared to 8% with placebo (p less than 0.0001). There
was a 66% improvement in the Dupixent every two weeks group and,
65% improvement in the Dupixent every four weeks group in average
percent change from baseline in EASI score compared with a 24%
improvement in the placebo group (p less than 0.0001). There was a
48% improvement in the Dupixent every two weeks group and 45.5%
improvement in the Dupixent every four weeks group in average
percent change from baseline in the pruritus numerical rating scale
(NRS) compared with a 19% improvement in the placebo group (p less
than 0.0001). "Current treatment options for these adolescent
patients such as topical steroids, oral steroids, and non-steroidal
immunosuppressants can have significant side effects," said Elias
Zerhouni, M.D., President, Global R&D, Sanofi. "We continue to
explore Dupixent's role in targeting Type 2 inflammation as an
underlying cause of atopic dermatitis to potentially provide
adolescents, some of whom have lived with this disease their entire
lives, a therapy that treats more than just their symptoms."
Dupixent safety profile was consistent with that seen in
adults For the 16-week treatment period, the overall rate of
adverse events was comparable between the Dupixent groups and
placebo (72% for Dupixent every two weeks, 64% for Dupixent every
four weeks and 69% for placebo). There were no serious adverse
events or events leading to treatment discontinuation in either
Dupixent treatment group. Adverse events that were observed at a
higher rate with Dupixent included injection site reactions (8.5%
for Dupixent every two weeks, 6% for Dupixent every four weeks
compared with 3.5% for placebo) and conjunctivitis (10% for
Dupixent every two weeks, 11% for Dupixent every four weeks
compared with 5% for placebo). Skin infections were numerically
lower in the Dupixent groups (11% for Dupixent every two weeks, 13%
for Dupixent every four weeks compared with 20% for placebo).
Detailed results from this trial will be presented at a
future medical meeting. These data will be submitted to regulatory
authorities later this year. In 2016, the U.S. Food and Drug
Administration (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 safety and efficacy of Dupixent in the adolescent atopic
dermatitis population have not been fully evaluated by any
regulatory authority. About the Dupixent Trial in Adolescent
Patients The pivotal, Phase 3, randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent monotherapy in adolescent patients with moderate-to-severe
atopic dermatitis. The trial enrolled 251 patients who were 12
years to 17 years of age with moderate-to-severe atopic dermatitis
whose disease could not be adequately controlled with topical
medications or for whom topical treatment was medically
inadvisable. In total, 92% of these patients suffered from at least
one concurrent allergic condition such as allergic rhinitis, asthma
or food allergy. The primary endpoint of this trial was the
proportion of patients with an IGA score of 0 or 1 at Week 16. The
IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) that
measures overall severity of skin lesions. A co-primary endpoint
outside of the U.S. and a key secondary endpoint in the U.S. was
the proportion of patients who achieved 75% or greater skin
improvement as measured by the EASI-75 at Week 16. EASI is a tool
used to measure the extent and severity of the disease. Patients
were randomized into one of three treatment groups for the
controlled period of 16 weeks: the first group was treated with
Dupixent subcutaneous injection 200 mg or 300 mg every two weeks,
based on weight (with an initial dose of 400 mg or 600 mg
respectively). The second group was treated with 300 mg Dupixent
every four weeks (with an initial dose of 600 mg), and the third
group was treated with placebo every two weeks. About
Moderate-to-Severe Atopic Dermatitis Atopic dermatitis, a form
of eczema, is a chronic inflammatory disease with symptoms often
appearing as a rash on the skin[i][ii][iii][iv]. Moderate-to-severe
atopic dermatitis is characterized by rashes often covering much of
the body, and can include intense, persistent itching and skin
dryness, cracking, redness, crusting, and oozing[v]. Itch is one of
the most burdensome symptoms for patients and can be
debilitating[vi]. In addition, patients with moderate-to-severe
atopic dermatitis experience a substantial burden of disease,
including painful skin lesions and intense pruritus.6 Dupilumab
Development Program Sanofi and Regeneron are studying dupilumab
in a broad range of clinical development programs for diseases
driven by Type 2 inflammation, including asthma (Phase 3),
pediatric atopic dermatitis (Phase 3, ages 6 months - 11 years),
nasal polyps (Phase 3) and eosinophilic esophagitis (Phase 2).
Future trials are planned for chronic obstructive pulmonary
disease, grass allergy and food allergy (including peanut). 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 a global
collaboration agreement. For more information on dupilumab clinical
trials please visit www.clinicaltrials.gov. About Dupixent®
(dupilumab) Dupixent is currently approved in the U.S. for the
treatment of adults with moderate-to-severe atopic dermatitis whose
disease is not adequately controlled with topical prescription
therapies, or when those therapies are not advisable. Dupixent is
also approved for use in certain patients with moderate-to-severe
atopic dermatitis in a number of other countries, including the
countries of the European Union, Canada, and Japan. The safety and
efficacy of Dupixent in the adolescent atopic dermatitis population
have not been fully evaluated by any regulatory authority. In
addition, the potential use of Dupixent for the treatment of
certain adults and adolescents with inadequately controlled
moderate-to-severe asthma is currently under regulatory review in
the U.S. and European Union, and the safety and efficacy for this
use have not been fully evaluated by any regulatory authority.
INDICATION Dupixent is used to treat adult patients with
moderate-to-severe atopic dermatitis (eczema) that is not well
controlled with prescription therapies used on the skin (topical),
or who cannot use topical therapies. Dupixent can be used with
or without topical corticosteroids. It is not known if Dupixent is
safe and effective in children. Dupixent is administered by
subcutaneous injection at different injection sites every two weeks
after an initial loading dose. Dupixent is intended for use under
the guidance of a healthcare provider. A patient may self-inject
Dupixent after training in subcutaneous injection technique using
the pre-filled syringe. |
About Sanofi Sanofi is dedicated to supporting
people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions. With
more than 100,000 people in 100 countries, Sanofi is transforming
scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life |
About Regeneron Pharmaceuticals, Inc 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 six 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, heart disease, allergic and inflammatory
diseases, pain, cancer, infectious diseases 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. |
Sanofi Media Relations ContactAshleigh KossTel.:
+1 908-981-8745mr@sanofi.com |
Investor Relations
Contact George Grofik Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com |
Regeneron Media Relations ContactSharon
ChenTel.: +1 914-847-1546 sharon.chen@regeneron.com |
Regeneron Investor
Relations ContactManisha Narasimhan, Ph.D.Tel: +1
914-847-5126Manisha.narasimhan@regeneron.com |
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[i] Eichenfield et al. Guidelines of Care for Atopic
Dermatitis. AAD 2014, pp. 118.[ii]Guideline to treatment, European
Dermatology Forum.
http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous?download=36:guideline-treatment-of-atopic-eczema-atopic-dermatitis.
Accessed December 23, 2016[iii]Gelmetti and Wolleberg, BJD 2014,
Atopic dermatitis- all you can do from the outside. Page
19.[iv]National Institutes of Health (NIH). Handout on Health:
Atopic Dermatitis (A type of eczema) 2013.
http://www.niams.nih.gov/Health_Info/Atopic_Dermatitis/default.asp.
Accessed October 31, 2016.[v]Mount Sinai. Patient Care Atopic
Dermatitis. Available at:
http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk.
Accessed August 2017.[vi]Zuberbier T et al. Patient perspectives on
the management of atopic dermatitis. J Allergy Clin Immunol vol.
118, pp. 226-232, 2006. |