TGA gives green light to Sanofi’s first biological therapy for COPD

The first biological therapy for the treatment of uncontrolled chronic obstructive pulmonary disease (COPD) has been registered in the Australian Register of Therapeutic Goods (ARTG).

The expanded indication means that Sanofi’s Dupixent (dupilumab) is now indicated in adults as add-on maintenance treatment for uncontrolled COPD characterised by raised blood eosinophils who are on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.

Professor Philip Bardin, Director, Lung, Sleep, Allergy & Immunology at Monash University and Medical Centre, said “Dupilumab acts to address the underlying cause of inflammation in these patients, thereby delaying disease progression. Despite the widespread use of inhaled medications for COPD, this complex inflammatory airways disease remains one of the leading cause of preventable hospital admissions in Australia.

“It is concerning that one-in-two COPD patients experience exacerbations despite receiving triple inhaled therapy. We also know that COPD patients with an eosinophilic phenotype have a 30% greater risk of exacerbations than those without an eosinophilic phenotype.

“Belonging to the first new class of treatment for COPD in more than a decade, dupilumab has the potential to change the way a severe form of this debilitating disease is managed.”

Dupixent is the first and only registered monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.

Professor Bardin further explained “By blocking two cytokines dupilumab helps reduce swelling in the lungs of people with COPD and high eosinophil levels. Dupilumab is the first and only biological medicine shown to reduce the frequency and severity of COPD symptoms and exacerbations.

“We know that up to 40% of people with COPD have an eosinophilic phenotype. Dupilumab has the potential to significantly delay disease progression in inadequately controlled eosinophilic COPD patients.”

James Scott, Medical Head, Pharma, Sanofi Australia and New Zealand, said “Dupixent has already transformed the treatment of severe atopic dermatitis and a severe form of asthma in Australia.

“Respiratory specialists have extensive experience with biologics in asthma, but this is the first time they can use a monoclonal antibody therapy for COPD. In caring for people living with COPD, preventing symptoms from worsening is crucial for patient quality of life.

“That’s why we’re optimistic about the role Dupixent may play in addressing the significant burden of uncontrolled COPD on thousands of Australian patients, but particularly those in regional and remote Australia who are three times more likely to be hospitalised due to COPD exacerbations,” he said.

The expanded indication for Dupixent 300mg/2mL is based on findings from the landmark phase 3 BOREAS and NOTUS studies, found that when added to inhaled triple therapy (LABA, LAMA and ICS), fortnightly subcutaneous injections of Dupixent 300mg/2mL delivered 30% and 34% reductions in the annualised rate of moderate or severe COPD exacerbations over 52 weeks.

Additionally, improvements in lung function (pre-bronchodilator FEV1) from baseline by 160 mL and 139 mL (compared to 77 mL and 57 mL respectively) were observed at 12 weeks.

Scott added, “Sanofi will work closely with all stakeholders to take the next steps required towards Pharmaceutical Benefits Scheme reimbursement of Dupixent for eligible COPD patients.”

The drug is currently not listed for evaluation on the the March or May PBAC agenda.

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