CHMP recommends approval of Dupixent (dupilumab) for asthma indication


PARIS and TARRYTOWN, NY –  The European Medicines Agency’s
Committee for Medicinal Products for Human Use (CHMP) has adopted a positive
opinion for Dupixent® (dupilumab), recommending its approval in the European Union
for use in adults and adolescents 12 years and older as add-on maintenance treatment
for severe asthma with type 2 inflammation characterized by raised blood eosinophils
and/or raised FeNO who are inadequately controlled with high dose inhaled
corticosteroid plus another medicinal product for maintenance treatment.
The positive CHMP opinion is based on clinical data from 2,888 adults and adolescents
who participated in three pivotal trials from the global LIBERTY ASTHMA program,
including the Phase 3 QUEST and VENTURE trials. QUEST compared Dupixent vs.
placebo in asthma patients inadequately controlled on a medium or high dose inhaled
corticosteroid and a second controller medication. VENTURE compared Dupixent vs.
placebo in oral corticosteroid dependent asthma patients. The European Commission is
expected to make a final decision on the application for Dupixent in the coming months.
Dupixent is a human monoclonal antibody that inhibits the signaling of interleukin-4 (IL4) and interleukin-13 (IL-13), two key proteins that play a central role in type 2
inflammation that underlies specific types of asthma as well as several other allergic
diseases. This effect is associated with the reduction of type 2 inflammatory biomarkers
including fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3
(CCL26).
Patients with severe asthma often have uncontrolled, persistent symptoms despite
standard-of-care therapy that may make them suitable for treatment with a biologic
therapy. Symptoms of uncontrolled disease include coughing, wheezing and difficulty
breathing, and these patients are at risk of severe asthma attacks that may require
emergency room visits or hospitalizations. Oral corticosteroids can provide relief for
severe, short-term symptoms; however, current asthma guidelines suggest limiting their
chronic use to the most severe patients due to the potential for serious side effects.
Dupixent is being developed jointly by Sanofi and Regeneron as part of a global
collaboration agreement. In October 2018, Dupixent was approved in the U.S. as an
add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years
and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Dupixent is not used to treat sudden breathing problems. Dupixent is currently under
regulatory review for specific types of asthma in Japan.
Dupixent is currently approved in the European Union for use in adults with moderate-tosevere atopic dermatitis who are candidates for systemic therapy. Dupixent is also
approved for use in specific patients with moderate-to-severe atopic dermatitis in a
number of other countries around the world.
Dupilumab development program
Sanofi and Regeneron are also studying dupilumab in a broad range of clinical
development programs for diseases driven by type 2 inflammation, including chronic
rhinosinusitis with nasal polyps (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), adolescent (12 to 17 years of age) atopic dermatitis (Phase 3 completed),
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.
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 FDAapproved 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, 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
Media Relations Contact
Ashleigh Koss
Tel.: +1 (908) 981-8745
Ashleigh.Koss@sanofi.com
Regeneron Media Relations Contact
Sharon Chen
Tel: +1 (914) 847-5018
Sharon.chen@regeneron.com
Investor Relations Contact
George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Regeneron Investor Relations Contact
Mark Hudson
Tel: +1 (914) 847-3482
Mark.Hudson@regeneron.com
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not historical facts. These statements include projections and
estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”,
“plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information
and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or
government regulation generally, that could affect the availability or commercial potential of the product, the absence of
guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including
future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety,
quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future
litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or
identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended
December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Regeneron Forward-Looking Statements
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ
materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,”
“estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although
not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties
include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s products, product
candidates, and research and clinical programs now underway or planned, including without limitation Dupixent®
(dupilumab)
Injection; the impact of the opinion adopted by the European Medicine Agency’s Committee for Medicinal Products for Human
Use discussed in this news release on the European Commission’s decision regarding the Marketing Authorization Application
for Dupixent for use as an add-on maintenance treatment for adults and adolescents (12 years and older) who have severe
asthma with type 2 inflammation and who are inadequately controlled with medium-to-high dose inhaled corticosteroid plus
another medicinal product for maintenance treatment, and for the treatment of oral corticosteroid-dependent asthma regardless
of type 2 inflammatory biomarkers; the likelihood, timing, and scope of possible regulatory approval and commercial launch of
Regeneron’s late-stage product candidates and new indications for marketed products, including possible regulatory approval of
Dupixent in the European Union discussed in this news release and possible regulatory approval of Dupixent in other
jurisdictions and indications (such as for the treatment of pediatric and adolescent atopic dermatitis, pediatric asthma, chronic
rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, food allergy (including peanut), chronic obstructive
pulmonary disease, and other potential indications (as well as in combination with REGN3500)); unforeseen safety issues
resulting from the administration of products and product candidates (such as Dupixent) in patients, including serious
complications or side effects in connection with the use of Regeneron’s product candidates in clinical trials; ongoing regulatory
obligations and oversight impacting Regeneron’s marketed products (such as Dupixent), research and clinical programs, and
business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities
which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product
candidates, including without limitation Dupixent; the availability and extent of reimbursement of the Company’s products (such
as Dupixent) from third-party payers, including private payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage
and reimbursement determinations by such payers and new policies and procedures adopted by such payers; uncertainty of
market acceptance and commercial success of Regeneron’s products and product candidates (such as Dupixent) and the
impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success
of any such products and product candidates; competing drugs and product candidates that may be superior to Regeneron’s
products and product candidates; the extent to which the results from the research and development programs conducted by
Regeneron or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of Regeneron
to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s
collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labeling, distribution, and other steps related
to Regeneron’s products and product candidates; unanticipated expenses; the costs of developing, producing, and selling
products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions
underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron’s
agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as
applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of
other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating
to EYLEA®
(aflibercept) Injection, Dupixent, and Praluent®
(alirocumab) Injection, the ultimate outcome of any such litigation
proceedings, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and
financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the
U.S. Securities and Exchange Commission, including its Form 10-Q for the quarterly period ended September 30, 2018. Any
forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to
rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly
any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new
information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the
Company, including information that may be deemed material to investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron’s media and investor relations website (http://newsroom.regeneron.com) and
its Twitter feed (http://twitter.com/regeneron).

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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