CHMP recommends approval of Dupixent® (dupilumab) ▼ for severe asthma indication[i]
GUILDFORD, UK – March 4, 2019 - 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.[I]
The UK has some of the highest asthma prevalence rates in Europe with asthma deaths increasing by 25 percent from 2007 to 2017 (1,033 deaths in 2007, 1,320 in 2017).[ii] 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.[v] 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.[vi],[vii],[viii] 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.[ix] 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.[x]
“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 2,888 adults and adolescents who participated in three pivotal trials from the global LIBERTY ASTHMA programme, including the Phase 3 QUEST and VENTURE trials.[iii],[iv] 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.
The European Commission is expected to make a final decision on the application for dupilumab in the coming months.
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. Dupilumab was granted a marketing authorisation in the EU in September 2017 for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Regeneron and Sanofi jointly develop dupilumab under a global collaboration agreement.
The full summary of product characteristics for dupilumab can be accessed at: https://www.medicines.org.uk/emc/product/8553/smpc.
[v] 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.
[vi] 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.
[vii] 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.
[viii] 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.
[x] Asthma UK. (2016). Tests for severe asthma. [Online]. Available at: https://www.asthma.org.uk/advice/severe-asthma/diagnosing-severe-asthma/tests-for-severe-asthma/ (Last accessed March 2019).