Sanofi and Regeneron’s Dupixent (dupilumab) has received positive final draft guidance from the National Institute for Health and Care Excellence (NICE), recommending it for NHS reimbursement as an add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD).
COPD refers to a group of lung disorders caused by obstruction or narrowing of the airways. COPD can be debilitating, with symptoms such as persistent cough and shortness of breath inhibiting daily activities and sometimes leading to anxiety, depression and problems sleeping.
Around 1.4 million people in the UK are diagnosed with COPD, but estimates suggest that a further two million might be living with undiagnosed COPD.
Dupixent was granted marketing approval in September 2024, following the phase 3 BOREAS and NOTUS studies. The studies evaluated the treatment in adults who were current or former smokers and had moderate-to-severe COPD with evidence of type 2 inflammation.
Participants in the studies received either Dupixent or placebo. The studies’ primary endpoint related to the annualised rate of moderate (requiring systemic steroids or antibiotics) or severe (requiring hospitalisation or emergency department observation, or resulting in death) COPD exacerbations.
Dupixent is a monoclonal antibody treatment designed to block the signalling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways, which are associated with driving type 2 inflammation. It has already received regulatory approvals in over 60 countries, in indications such as atopic dermatitis, asthma, prurigo nodularis and chronic spontaneous urticaria.
Sanofi and Regeneron are jointly developing Dupixent as part of their global collaboration.
Ahmed Moussa, country lead at Sanofi UK and Ireland, said: “Subject to Final Guidance, dupilumab would become the first targeted biologic reimbursed for COPD in the UK and comes after years of limited innovation in this area. Our next task will be to work together to ensure a positive decision is followed by clear implementation.”