MHRA authorization of Dupixent (dupilumab) marks a significant step forward as the UK moves closer to the first ever targeted biologic for the treatment of uncontrolled COPD

MHRA authorization of Dupixent (dupilumab) marks a significant step forward as the UK moves closer to the first ever targeted biologic for the treatment of uncontrolled COPD

• The Medicines and Healthcare products Regulatory Agency (MHRA) approval of Dupixent (dupilumab) for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils provides a new treatment option as the first-ever targeted biologic for uncontrolled COPD.^[i],[ii]
• Authorisation is based on two replicate phase 3 studies showing dupilumab significantly reduced exacerbations and improved lung function.^[iii],[iv]
• National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) will now review dupilumab for reimbursement.

Reading, 11^th September 2024: Today, Sanofi are pleased to announce the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-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 is the first-ever targeted biologic for people with uncontrolled COPD in the UK.^1,2 National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) will now review dupilumab for reimbursement.

The MHRA decision follows the European Medicines Agency’s (EMA) approval of dupilumab in July 2024, which was the first regulatory authority in the world to approve dupilumab for COPD patients. Additional submissions of dupilumab are under review with other regulatory authorities around the world, including in the United States (US), China, and Japan.

Rippon Ubhi

Country Lead, Sanofi UK & Ireland

“Today’s approval represents a significant shift in the longstanding treatment landscape for COPD patients. It marks the first time in more than a decade that we’ve seen a meaningful change in the treatments available to physicians to combat this devastating disease. Respiratory illnesses are the third biggest cause of death in the UK behind cancer and cardiovascular disease. Over 20,000 people with COPD die every year in the UK.

“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 impact of COPD in the UK

Lung disease has a significant economic burden on the NHS, costing around £9.6bn each year, which is 3.4% of the total NHS budget.^[v] COPD is a common group of lung conditions which are a significant public health issue in the UK. It is the second most common cause of emergency hospital admissions, accounting for one in eight visits to UK hospitals,^[vi],[vii] and presents a major health inequality, as COPD prevalence is four times higher in the most deprived areas compared to the least deprived areas.^[viii]

Symptoms of COPD, including persistent cough, excessive mucus production and shortness of breath, are associated with a significant impact on quality of life, and as symptoms get progressively worse, they can compromise a person’s ability to take part in day-to-day tasks.^[ix]

Phase III information

The MHRA approval is based on results from two replicate phase 3 BOREAS and NOTUS studies, which were separately published in The New England Journal of Medicine (NEJM) and evaluated the efficacy and safety of dupilumab in adults with uncontrolled COPD with evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL).^3,4 All patients were on background maximal standard-of-care inhaled therapy (with nearly all on triple therapy). Compared to placebo(BOREAS n=471; NOTUS n=465), dupilumab patients in BOREAS (n=468) and NOTUS (n=470) experienced the following, respectively: ^3,4

• Thirty percent and 34% reduction in the annualised rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint.
• Improvements in lung function (pre-bronchodilator FEV1) from baseline by 160 mL and 139 mL at 12 weeks compared to 77 mL and 57 mL for placebo. These improvements were observed as early as week 2 and 4 and were sustained at 52 weeks in both studies.
• Improvements in health-related quality of life (statistically significant in BOREAS and nominally significant in NOTUS), as assessed by the St. George’s Respiratory Questionnaire.

Safety results in both studies were generally consistent with the known safety profile of dupilumab in its approved indications. The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. Adverse events (AEs) more commonly observed with dupilumab (≥5%) compared to placebo in either COPD study were back pain, COVID-19, diarrhoea, headache and nasopharyngitis. Additional adverse reactions of injection site bruising, injection site induration, injection site rash and injection site dermatitis were reported in the COPD studies.^3,4