Dupilumab label expanded for severe asthma indication

The European Medicines Agency’s

Committee for

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.