EU approves Dupixent for severe asthma

The European Commission has approved Dupixent (dupilumab), from Sanofi, 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.

The EC approval is based on clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the global LIBERTY ASTHMA program, including the Phase III QUEST and VENTURE trials and a Phase IIb trial. QUEST enrolled 1,902 patients with persistent asthma and evaluated whether adding Dupixent to standard-of-care therapy could reduce severe exacerbations and improve lung function (measured by FEV1). VENTURE enrolled 210 patients with severe oral corticosteroid-dependent asthma and evaluated whether adding Dupixent to standard-of-care therapy could reduce the use of maintenance oral corticosteroids. The Phase IIb trial enrolled 776 adult patients with moderate-to-severe asthma and evaluated whether adding Dupixent to standard-of-care therapy could improve lung function.

Comment: Dupixent is also approved in the EU for the treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. In October 2018, Dupixent was approved in the U.S. as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. It is also approved in the U.S. for adults and adolescents (12 to 17 years of age) with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.