GUILDFORD, England,
May 8, 2019 /PRNewswire/ --
FOR UK MEDIA ONLY
- The first biologic licensed in the EU for severe asthma with
type 2 inflammation, as characterised by raised blood eosinophils
and/or raised fractional exhaled nitric oxide
(FeNO)1
- In clinical trials, patients who received Dupixent®
(dupilumab) had significantly lower rates of severe asthma
exacerbation than those who received placebo (standard of care), as
well as better lung function and asthma control2,3
- The UK has some of the highest asthma prevalence rates in
Europe, where there are on average
three deaths per day due to asthma4
The European Commission (EC) has licensed Dupixent®
(dupilumab) for use in adults and adolescents 12 years and older as
an add-on maintenance treatment for severe asthma with type 2
inflammation characterized by raised blood eosinophils and/or
raised fractional exhaled nitric oxide (FeNO), who are inadequately
controlled with high dose inhaled corticosteroid (ICS) plus another
medicinal product for maintenance treatment.1 The
decision from the EC follows a positive opinion from the Committee
for Medicinal Products for Human Use (CHMP) on 4 March 2019.
Patients receiving standard-of-care therapy for severe asthma
sometimes have uncontrolled, persistent
symptoms.5 Symptoms can include coughing, wheezing
and difficulty breathing, and these patients are at risk of severe
asthma attacks that may require emergency department visits or
hospitalisations.6,7,8 While ~1% of asthma patients
(54,000 in the UK) have a severe, uncontrolled form of asthma,
these patients account for substantial asthma-related healthcare
resource use and costs.9 The burden on quality of
life is considerable, including frequent exacerbations,
life-threatening attacks, and increased comorbidity
burden.10
"There has been an urgent need to continue investigating new
classes of medicines which can treat severe asthma symptoms
characterised by type 2 inflammation," said Professor Pavord,
Professor of Respiratory Medicine, Nuffield Department of Medicine,
University of Oxford. "As one of the
lead trial investigators for dupilumab, the results of our clinical
trial programme demonstrate the effect of dupilumab on asthma
exacerbations, oral corticosteroid use and overall lung function
compared to current standard of care, which is the basis for its
new licence. The arrival of this therapy, I believe, offers an
important new option for respiratory clinicians to manage their
patients."
Dupilumab is a human monoclonal antibody that inhibits the
signaling of interleukin-4 (IL-4) 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 FeNO and immunoglobulin E
(IgE).
"We of course welcome the positive EC decision, which is an
important milestone for this innovative treatment, first licensed
in atopic dermatitis," said Dr Jasmin
Hussein, Head of Dermatology and Respiratory, Sanofi
Genzyme. "We are now working closely with the NHS to ensure this
treatment is made available to appropriate patients in the UK
for whom this treatment is indicated."
About Dupixent® (dupilumab)
Dupixent®
(dupilumab) is a human monoclonal antibody that is designed to
specifically inhibit overactive signaling of two key proteins,
interleukin-4 and interleukin-13 (IL-4 and IL-13), which are
believed to be major drivers of the persistent underlying
inflammation in asthma and atopic dermatitis. In March 2019, the CHMP recommended its license 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 characterised by raised blood eosinophils and/or
raised fractional exhaled nitric oxide (FeNO), who are inadequately
controlled with high dose inhaled corticosteroid plus another
medicinal product for maintenance treatment.
Regeneron and Sanofi jointly develop dupilumab under a global
collaboration agreement.
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.
For more information please visit www.sanofi.co.uk.
[1] European Medicines Agency. (2019). [Online]. Available
at: https://www.ema.europa.eu/en (Last accessed May 2019).
[2] Castro M, Corren J, Pavord ID, et al. Dupilumab
Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N
Engl J Med 2018;378:2486-96.
[3] Rabe KF, Parameswaran N, Brusselle G, et al. Efficacy
and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma.
N Engl J Med 2018;378:2475-85.
[4] Asthma UK. (2018). Asthma deaths in England and Wales are the highest this century. [Online].
Available at:
https://www.asthma.org.uk/about/media/news/statement-asthma-deaths-in-england-and-wales-are-the-highest-this-century/
(Last accessed May 2019).
[5] Chung KF, Wenzel SE, Brozek JL, et al. (2014).
International ERS/ATS guidelines on definition, evaluation and
treatment of severe asthma. Eur Respir J 2014; 43: 343–373.
[6] Haselkorn T, Fish JE, Zeiger RS, et al.
Consistently very poorly controlled asthma, as defined by the
impairment domain of the Expert Panel Report 3 guidelines,
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2009;124(5):895-902.
[7] O'Byrne PM, Pedersen S, Lamm CJ, et al. Severe
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Respir Crit Care Med. 2009;179(1):19-24.
[8] Suruki, Robert Y, Daugherty JB, Boudiaf N, et
al. The Frequency of Asthma Exacerbations and Healthcare
Utilization in Patients with Asthma from the UK and USA. BMC Pulmonary Medicine
2017;17:74.
[9] Kerkhof M, Tran TN, Soriano JB, et al Healthcare
resource use and costs of severe, uncontrolled eosinophilic asthma
in the UK general population Thorax 2018;73:116-124.
[10] McDonald VM, Hiles SA, Jones KA, et al. Health-related
quality of life burden in severe asthma. Med J Aust 2018; 209 (2
Suppl): S28-S33.