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Sanofi Announces Licensing of Dupixent® ▼ (dupilumab) in the EU for the Treatment of Severe Asthma With Type 2 Inflammation

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, increases risk for future severe asthma exacerbations in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. J Allergy Clin. 2009;124(5):895-902.

[7] O'Byrne PM, Pedersen S, Lamm CJ, et al. Severe exacerbations and decline in lung function in asthma. Am J 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.