Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) 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 biologic for uncontrolled COPD in the UK.
Patients eligible for the therapy will also already be receiving a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or a LABA/LAMA combination if ICS is not appropriate.
The marketing authorisation, which comes just two months after Dupixent was approved by the European Medicines Agency (EMA) for the same indication, was supported by positive results from the late-stage BOREAS and NOTUS trials of the therapy in adults with uncontrolled COPD and evidence of type 2 inflammation. All patients were on background maximal standard-of-care inhaled therapy, with nearly all on triple therapy.
Dupixent demonstrated a 30% and 34% reduction in annualised moderate or severe COPD exacerbations compared to placebo over one year in BOREAS and NOTUS, respectively.
Improvements in lung function were seen as early as weeks two and four in Dupixent-treated patients and were sustained at one year in both studies. The therapy was also shown to improve health-related quality of life, as assessed by the St George’s Respiratory Questionnaire.
Approximately 1.4 million people in the UK have been diagnosed with COPD, a chronic respiratory disease that causes progressive lung function decline and results in symptoms such as persistent cough, excessive mucus production and a shortness of breath.
Already approved for a range of indications, Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases, including COPD.
Rippon Ubhi, country lead, Sanofi UK and Ireland, said the latest Dupixent authorisation “represents a significant shift in the longstanding treatment landscape for COPD patients”.
She continued: “[Dupixent] 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.”
Also commenting on the approval, Henry Gregg, director of external affairs at Asthma + Lung UK, said: “In recent years little progress has been made in finding new treatments for COPD. It is therefore incredibly positive for some people affected by uncontrolled COPD that [Dupixent] has been approved by the MHRA.”
He continued: “[Dupixent] has already been approved by the EMA, so it’s good to see the UK follow suit and approve access to this new biologic treatment, which could make a real difference to the lives of people living with COPD. It will now be up to the National Institute for Health and Care Excellence to see if the use of [Dupixent] will be recommended for use by the NHS.”