Sanofi: FDA to undertake priority review of Dupixent® (dupilumab) for adults with inadequately controlled severe chronic rhi...
08 Marzo 2019 - 12:02AM
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Press
Release Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
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FDA to undertake priority review of Dupixent®
(dupilumab) for adults with inadequately controlled severe chronic
rhinosinusitis with nasal polyps
PARIS and TARRYTOWN, NY - March 8, 2019 -
The U.S. Food and Drug Administration (FDA) has accepted for
Priority Review the supplemental Biologics License Application
(sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment
for adults with inadequately controlled severe chronic
rhinosinusitis with nasal polyps (CRSwNP). Patients with severe
CRSwNP often experience recurrence despite previous treatment with
surgery and/or systemic corticosteroids. The target action date for
the FDA decision is June 26, 2019.
Currently, there are no FDA-approved biologic
medicines to treat CRSwNP, a chronic disease of the upper airway
predominantly driven by type 2 inflammation and characterized by
polyps that obstruct the sinuses and nasal passages. Patients may
experience severe nasal obstruction with breathing difficulties,
nasal discharge, reduction or loss of sense of smell and taste, and
facial pain or pressure. Persistent symptoms of CRSwNP have a
substantial adverse impact on patients' health-related quality of
life, which can be measured by a composite endpoint that includes
reduced productivity and activities of daily living, inablility to
enjoy food, lack of sleep and fatigue. People with co-morbid asthma
and CRSwNP tend to have more severe disease and are often more
difficult to treat.
The sBLA is supported by data from two pivotal
Phase 3 trials evaluating the efficacy and safety of Dupixent when
combined with standard-of-care corticosteroid nasal spray in
patients with recurring severe CRSwNP despite previous treatment
with surgery and/or systemic corticosteroids. About 60% of patients
in the trials had co-morbid asthma. Data from these trials were
presented at the Annual Meeting of the American Academy of Allergy,
Asthma & Immunology (AAAAI) in February 2019. In addition to
moderate-to-severe atopic dermatitis and moderate-to-severe asthma,
this is the third type 2 allergic inflammatory disease in which
Dupixent has demonstrated positive Phase 3 results.
Dupixent is a targeted biologic therapy that
inhibits signaling of interleukin-4 (IL-4) and interleukin-13
(IL-13), two key proteins that may play a central role in type 2
inflammation, which seem to underlie CRSwNP as well as several
other allergic diseases.
In the U.S., Dupixent is approved for the
treatment of adults 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 is also approved for use with other asthma
medicines for the maintenance treatment of moderate-to-severe
asthma in people aged 12 years and older whose asthma is not
controlled on their current asthma medicines. Dupixent is also
approved for use in certain adult patients with moderate-to-severe
atopic dermatitis in countries of the European Union (EU), and
other countries including Canada and Japan.
On March 1, 2019, the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) adopted a positive opinion for the application for Dupixent,
recommending its approval in the EU as add-on maintenance treatment
for adult and adolescent (12 years and older) severe asthma
patients with type 2 inflammation characterized by increased blood
eosinophils and/or raised exhaled nitric oxide measured by FeNO
test and inadequately controlled by inhaled high dose
corticosteroids plus another asthma medicinal product. This
indication remains investigational in the EU, pending the adoption
of the CHMP opinion by the European Commission. Other potential
uses for Dupixent, including in CRSwNP, are investigational and the
safety and efficacy have not been evaluated by the U.S. Food and
Drug Administration, the EMA or any other regulatory authority.
Dupilumab is being developed jointly by Sanofi and Regeneron as
part of a global collaboration agreement.
Dupilumab development program
In 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 chronic
rhinosinusitis with nasal polyps (Phase 3 completed), adolescent
(12 to 17 years of age) atopic dermatitis (Phase 3 completed),
pediatric (6 to 11 years of age) atopic dermatitis (Phase 3),
pediatric (6 months to 5 years of age) atopic dermatitis (Phase
2/3), pediatric (6 to 11 years of age) asthma (Phase 3),
eosinophilic esophagitis (Phase 2/3), and food and environmental
allergies (Phase 2). A future trial is planned for chronic
obstructive pulmonary disease. Dupilumab is also being studied in
combination with REGN3500, which targets IL-33. These potential
uses are investigational and the safety and efficacy have not been
evaluated by any regulatory authority.
For more information on dupilumab clinical
trials please visit www.clinicaltrials.gov.
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 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
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, neuromuscular diseases,
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.
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 |
Sanofi Media Relations Contact Ashleigh Koss Tel.: +1
(908) 981-8745 Ashleigh.Koss@sanofi.com Regeneron Media
Relations ContactSharon ChenTel.: +1 (914)
847-5018Sharon.Chen@regeneron.com |
Sanofi
Investor Relations Contact George Grofik Tel.: +33 (0)1 53 77
45 45 ir@sanofi.com Regeneron Investor Relations ContactMark
HudsonTel.: +1 (914) 847-3482Mark.Hudson@regeneron.com |
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now underway or planned, including without limitation Dupixent®
(dupilumab) Injection; the likelihood, timing, and scope of
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rhinosinusitis with nasal polyps, pediatric atopic dermatitis,
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and other potential indications (as well as in combination with
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government shutdowns on the anticipated timing of the decision by
the U.S. Food and Drug Administration regarding the supplemental
Biologics License Application for Dupixent referenced in this press
release; the impact of the opinion adopted by the European Medicine
Agency's Committee for Medicinal Products for Human Use referenced
in this press release on the European Commission's decision
regarding the Marketing Authorization Application for Dupixent for
use as an add-on maintenance treatment in certain adults and
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