MHRA Approves Sanofi/Regeneron's Dupixent for Uncontrolled COPD
核心洞察
The MHRA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled COPD (搜索) and raised blood eosinophils.
Dupixent is the first targeted biologic approved in the UK for uncontrolled COPD (搜索), offering a new treatment option for eligible patients.
The approval is based on Phase 3 trials (BOREAS and NOTUS) demonstrating significant reductions in COPD (搜索) exacerbations and improved lung function.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Sanofi and Regeneron's Dupixent (dupilumab) as an add-on maintenance treatment for adults in the UK suffering from uncontrolled chronic obstructive pulmonary disease (COPD (搜索)) characterized by raised blood eosinophils. This decision marks Dupixent as the first-ever targeted biologic for uncontrolled COPD available in the UK.
Clinical Basis for Approval
The MHRA's authorization is grounded in the outcomes of two Phase 3 trials, BOREAS and NOTUS, which assessed Dupixent's efficacy and safety in adults with uncontrolled COPD (搜索) displaying evidence of type 2 inflammation, indicated by blood eosinophils ≥300 cells per μL. Participants in these trials were already undergoing maximal standard-of-care inhaled therapy, with most on triple therapy.
In the BOREAS and NOTUS studies, Dupixent demonstrated a 30% and 34% reduction, respectively, in the annualized rate of moderate or severe COPD (搜索) exacerbations over a 52-week period compared to placebo. Furthermore, improvements in lung function, measured by pre-bronchodilator FEV1, were observed as early as weeks two and four in Dupixent-treated patients, and these improvements were sustained at one year in both studies. The therapy also showed improvements in health-related quality of life, as measured by the St. George’s Respiratory Questionnaire.
Impact on COPD Treatment Landscape
"Today’s approval represents a significant shift in the longstanding treatment landscape for COPD (搜索) patients," said Rippon Ubhi, Country Lead, Sanofi UK & Ireland. "Dupilumab has been clinically shown to reduce COPD exacerbations and improve lung function, and it is our priority to work with regulatory bodies to ensure patients in the UK can access this important treatment option as soon as possible."
The Burden of COPD in the UK
Approximately 1.4 million people in the UK have been diagnosed with COPD (搜索), a chronic respiratory disease characterized by progressive lung function decline, leading to symptoms such as persistent cough, excessive mucus production, and shortness of breath. COPD is the second most common cause of emergency hospital admissions in the UK, accounting for one in eight visits to UK hospitals.
Mechanism of Action
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (搜索) and interleukin-13 (搜索) pathways. These pathways have been shown to be key drivers of the type 2 inflammation that plays a major role in multiple related diseases, including COPD (搜索).
Next Steps
Following the MHRA approval, the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) will now review Dupixent for reimbursement within their respective healthcare systems.