The monoclonal antibody dupilumab (brand name Dupixent) has become the first targeted treatment for chronic obstructive pulmonary disease (COPD) to be approved in final draft guidance by the National Institute for Health and Care Excellence (NICE).

Dupilumab is indicated as an add-on maintenance treatment for the approximately 30,000 adults in England who have uncontrolled COPD with raised blood eosinophils and have experienced at least one severe flare-up, or two or more moderate flare-ups, in the previous 12 months despite being on the maximum inhaler therapy.

A pre-filled injectable pen that patients can administer themselves at home every two weeks, dupilumab is the first biologic that targets both the symptoms and an underlying cause of the disease by blocking the interleukin-4 and interleukin-13 proteins.

With COPD causing around 130,000 emergency NHS hospital admissions each year in England, it is hoped that dupilumab could help ease pressure on hospitals while reducing the need for steroid prescriptions.

NICE estimates that if half the eligible population receive this new treatment, there could be around 3,600 fewer COPD attacks, saving the health service an estimated £16.5m.

Dupilumab efficacy

The NICE recommendation is based on the results of the phase 3 BOREAS and NOTUS trials.

These double-blind, randomised multicentre trials, saw participants randomised to either 300 mg dupilumab given subcutaneously once every two weeks or placebo for 52 weeks.

The primary outcome for both trials was adjusted annualised rate of moderate or severe exacerbations, with changes in prebronchodilator FEV1 and Saint George’s Respiratory Questionnaire (SGRQ) scores at weeks 12 and 52 as key secondary endpoints.

The pooled analysis comprised 938 people in the dupilumab arm and 936 people in the placebo arm.

Clinical trial participants reported significant improvements in breathing and lung capacity and the results found that dupilumab reduced COPD flare-ups by around 30%.

It was concluded that dupilumab reduced moderate-to-severe exacerbations and improved both the prebronchodilator FEV1 and the SGRQ score when compared with the placebo.

‘Most important breakthrough in COPD care in nearly a decade’

Helen Knight, director of medicines evaluation at NICE, described the approval as a ‘significant milestone’ for people with COPD.

‘It offers patients an effective, targeted therapy that has shown impressive results – reducing flare-ups by around a third while improving lung function,’ she said, adding that it’s better for both patients and the NHS.

Sarah Sleet, chief executive of the charity Asthma + Lung UK, welcomed the announcement, calling it ‘the most important breakthrough in COPD care in nearly a decade’.

She added: ‘While not everyone will be eligible for this drug, today’s announcement will bring hope to many who have not been able to access treatment that could transform their lives.’

NHS England has secured a commercial deal with manufacturer Sanofi enabling the rollout of dupilumab for eligible patients.

The final NICE guidance is expected to be published on 5 March 2026.

This article was originally published by our sister publication Hospital Pharmacy Europe.