Sanofi/Regeneron’s Dupixent set to dominate COPD biologics market following FDA approval

The US Food and Drug Administration (FDA) has announced the approval of Sanofi and Regeneron’s interleukin (IL)-4 and IL-13 monoclonal antibody, Dupixent, for the US market. The asset is tailored towards patients with moderate-to-severe exacerbations with chronic obstructive pulmonary disease (COPD), as an add-on maintenance treatment for uncontrolled COPD characterised by raised blood eosinophils on a combination of an inhaled corticosteroid, a long-acting beta-2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or a combination of a LABA and a LAMA. Dupixent has gained great traction and positive opinions from key opinion leaders (KOLs) due to the successful and consistent data presented from the asset’s two Phase III clinical trials, named NOTUS and BOREAS, as well as the large presence of Sanofi and Regeneron at the 2024 European Respiratory Society (ERS) Congress in Vienna, Austria, earlier in September. Dupixent’s approval is set to improve the treatment landscape for COPD and offer a treatment option with the potential to improve patients’ quality of life, and is expected to become a leader in the COPD biologics market.
Several months before the European Medicines Agency’s (EMA) and FDA’s approval, Sanofi and Regeneron’s Dupixent showed promising evidence of its benefit to COPD patients, namely a reduction in exacerbations. After reviewing the data published from Sanofi/Regeneron’s two landmark Phase III studies (BOREAS and NOTUS), Dupixent 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 to improve lung function at 12 weeks, sustained through 52 weeks, compared to placebo. In addition, the data presented at the 2024 ERS congress in Vienna has shown that Dupixent has the potential to improve quality of life, measured by the St George’s Respiratory Questionnaire 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 five-year mortality risk.
KOLs interviewed by leading data and analytics company GlobalData have shared optimistic views on Dupixent, noting that its novel pathway presents anti-mucous effects, which is an additive value, supplementing its anti-eosinophil effects. KOLs have also communicated that the data presented in the clinical trials gives a strong advantage to the asset and its place in the COPD market, perhaps even over other biologics in the COPD pipeline.

GlobalData forecasts total sales of Dupixent for COPD to reach $6.57bn in the seven major markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan) by 2033, which can be found in the COPD in the Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033 report. With the EMA taking the first step of approving the first biologic for COPD and the FDA following closely, adoption by patients with uncontrolled COPD will make Dupixent a leader to dominate the biologics market for this indication.