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Sunday 19 May 2019
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Dupilumab label expanded for severe asthma indication

The European Medicines Agency’s
Committee for
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab). 
 
The CHMP recommends 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.1
 
The UK has some of the highest asthma prevalence rates in Europe with asthma deaths increasing by 25% from 2007 to 2017 (1033 deaths in  2007, 1320 in 2017).2 Many patients with asthma have the severe  form, which can be life-threatening if not controlled. Patients receiving standard-of-care therapy for severe asthma may often still have  uncontrolled, persistent  symptoms.3 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.4,5,6 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.7 An Asthma UK survey found that people can  struggle to be diagnosed, with 55% taking a few years to be diagnosed with severe asthma following their initial asthma diagnosis.8
 
Patients with severe asthma can face a daily struggle, not knowing whether they will face  an  unpredictable  exacerbation, which can be frightening, and  if  uncontrolled, may lead to death,” said  Dr Jasmin Hussein,  Head of Dermatology and Respiratory, Sanofi Genzyme. “Today’s CHMP positive opinion for dupilumab marks an important milestone for patients with severe asthma, moving us one step closer to bringing another treatment option for this potentially life-threatening disease to those in greatest need.”
 
The positive CHMP opinion is based on clinical data from 2888 adults and adolescents who participated in three pivotal trials from the global  LIBERTY ASTHMA  programme, including the Phase III QUEST and VENTURE trials.9,10 QUEST compared dupilumab vs.placebo in asthma patients inadequately controlled on a medium or high dose inhaled corticosteroid and a second controller medication. VENTURE compared dupilumab vs. placebo in oral corticosteroid-dependent asthma patients.
 
References
  1. European Medicines Agency. (2019). Summary of opinion (post authorisation). [Online]. www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-dupixent-x-04-g_en.pdf(Last accessed March 2019). 
  2. Asthma UK. (2018). Asthma deaths in England and Wales are the highest this century. [Online]. www.asthma.org.uk/about/media/news/statement-asthma-deaths-in-england-and-wales-are-the-highest-this-century/(Last accessed March 2019).
  3. Chung KF et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014;43:343–373.
  4. Haselkorn T 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.
  5. O'Byrne PM et al. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009;179(1):19-24.
  6. Suruki R 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.
  7. Global Initiative for Asthma. Global Strategy For Asthma Management and Prevention, 2017. www.ginasthma.org. Last accessed December 2018.
  8. Asthma UK. (2016). Tests for severe asthma. [Online]. www.asthma.org.uk/advice/severe-asthma/diagnosing-severe-asthma/tests-for-severe-asthma/(Last accessed March 2019).
  9. Castro M et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med 2018;378:2486-96.
  10. Rabe KF et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med 2018;378:2475-85.irator