Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the European Medicines Agency (EMA) as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD).
The regulator’s decision specifically applies to adults with uncontrolled COPD characterised by raised blood eosinophils and makes Dupixent the first-ever targeted therapy for COPD in the EU and the first new treatment approach for the disease in more than a decade.
The approval covers patients already receiving an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or those on a LABA/LAMA combination if ICS is not appropriate.
COPD is a chronic respiratory disease that causes progressive lung function decline, with symptoms including a persistent cough, excessive mucus production and a shortness of breath that may impair the ability to perform routine daily activities.
Sanofi and Regeneron have outlined that there are approximately 220,000 COPD patients in the EU who could be eligible for treatment with Dupixent, a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways.
The EMA’s approval follows a recent recommendation from its human medicines committee and is supported by positive results from the late-stage BOREAS and NOTUS trials of Dupixent in adults with uncontrolled COPD and evidence of type 2 inflammation.
The primary endpoint was met in both studies, with Dupixent shown to significantly reduce annualised moderate or severe acute COPD exacerbations compared to placebo.
Improvements in lung function in Dupixent-treated patients were sustained at 52 weeks and the therapy was also shown to improve health-related quality of life at 52 weeks, as assessed by the St. George’s Respiratory Questionnaire.
Paul Hudson, Sanofi’s chief executive officer, said: “Patients with uncontrolled COPD have been waiting for a new treatment approach for many years, so we are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function.”
Dupixent already holds approvals for a range of indications, including for certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.
Regulatory submissions for use of the therapy in COPD are under review with other regulatory authorities around the world, including in the US.