Following the Food and Drug Administration (FDA) approval of Sanofi/Regeneron’s Dupixent (Dupilumab) on 27 September 2024:

Asiyah Nawab, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:

“Dupixent, a monoclonal antibody (mAb) targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, has been approved by the FDA as the first biologic for uncontrolled chronic obstructive pulmonary disease (COPD), closely following the European Medicines Agency (EMA) approval in early July 2024. It is to be used specifically as an add-on maintenance treatment, given alongside the standard of care (SoC), with 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. The approval is set to improve the treatment landscape for COPD and offer patients a treatment option with potential to improve quality of life.

“After reviewing the data published from Sanofi/Regeneron’s two landmark phase 3 studies (BOREAS and NOTUS), Dupixent (dupilumab) was able to significantly reduce moderate or severe acute COPD exacerbations by 30% in the BOREAS trial and by 34% in the NOTUS trial over 52 weeks, as well as improve lung function at 12 weeks, sustained through 52 weeks, compared to placebo. In addition, the data presented at the 2024 European Respiratory Society (ERS) congress in Vienna has shown that Dupixent has potential to improve quality of life, measured by the St George’s Respiratory Questionnaire (SGRQ) score, in patients with COPD and type-2 inflammation without exacerbations at Week 12. Other data presented at the 2024 ERS congress communicated that the asset reduced exacerbation rates and improved lung function in patients with COPD with moderate-to-severe airflow limitation, and type-2 inflammation, compared to placebo, irrespective of baseline 5-year mortality risk.

“Sanofi and Regeneron had great presence at the 2024 ERS congress this year, with two of three of their lunch-time symposia focusing on Dupixent and its use in COPD patients. Additional poster sessions, oral presentations and booth content added to the potential of Dupixent in the treatment paradigm of treating moderate-to-severe exacerbating COPD patients.

“The FDA’s approval of Dupixent has addressed the current gap in the US market for COPD – the absence of biologics. The key opinion leaders (KOLs) interviewed by GlobalData have shared optimistic views on Dupixent, noting that the data presented in the clinical trials brings a great advantage to the asset and to the COPD space, perhaps even over other biologics in the COPD pipeline.

“GlobalData’s “COPD in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033” report forecasts the total sales of Dupixent for COPD to reach $6.57 billion in the 7MM (US, France, Germany, Italy, Spain, UK and Japan) by 2033. With the EMA taking the first step of approving the first biologic for COPD and the FDA having closely followed, the adoption of Dupixent for uncontrolled patients in the respiratory space has the potential to dominate the biologics market share.”