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World-first approval for dupilumab in targeting uncontrolled COPD

The monoclonal antibody dupilumab (brand name Dupixent) has been approved by the European Commission for eligible adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils.

The first-ever targeted therapy to be approved for patients with COPD, dupilumab is now indicated as an add-on maintenance treatment for patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.

Dupilumab targets interleukin-4 and interleukin-13 pathways – the key drivers of type 2 inflammation – and is the first biologic approved for COPD, as well as being the first new treatment for the disease approved in Europe for over a decade.

Sanofi and Regeneron estimate that around 220,000 patients with COPD in the EU could be eligible for treatment with dupilumab.

Safety and efficacy of dupilumab

The approval is based on results from the phase 3 BOREAS and NOTUS trials, which evaluated the efficacy and safety of dupilumab in adults who had uncontrolled COPD with blood eosinophils ≥300 cells per μL.

The primary endpoint in both trials was the annualised rate of moderate or severe exacerbations.

Patients were on background maximal standard-of-care inhaled therapy, with nearly all on triple therapy, and were randomised to receive subcutaneous dupilumab (300 mg) or placebo every two weeks.

Dupilumab patients in BOREAS (n=468) experienced a 30% reduction in the annualised rate of moderate or severe COPD exacerbations over 52 weeks compared to placebo (BOREAS n=471).

In NOTUS (n=470) this was a 34% reduction compared to placebo (NOTUS n=465).

In terms of the secondary and other endpoints, there were improvements in lung function (prebronchodilator FEV1) from baseline by 160 mL and 139 mL at 12 weeks compared to 77 mL and 57 mL in the placebo group. These were observed as early as Week 2 and 4 and were sustained at Week 52 in both trials.

The researchers also noted improvements in health-related quality of life, which was statistically significant in BOREAS and nominally significant in NOTUS, as assessed by the St. George’s Respiratory Questionnaire.

Safety results in both studies were found to largely be consistent with the known safety profile of dupilumab in its approved indications.

‘Redefine the treatment landscape’

Speaking of dupilumab’s potential to ‘redefine the treatment landscape’ of COPD, George D. Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, said: ‘The approval of Dupixent for COPD is a long-awaited turning point for those who struggle to breathe even through the simplest of tasks, while also facing the risk of hospitalisation, irreversible health decline and feelings of hopelessness.’

Paul Hudson, chief executive officer at Sanofi, added: ‘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.’

This latest approval means dupilumab is indicated for certain patients with six conditions in the EU: moderate-to-severe atopic dermatitis, severe asthma, chronic rhinosinusitis with nasal polyposis, moderate-to-severe prurigo nodularis, eosinophilic oesophagitis, and now COPD.