EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD, says GlobalData

03 Jul, 2024 EMA approval of Sanofi/Regeneron's Dupixent fills biologic gap in COPD, says GlobalData

Posted in Pharma

Following the European Medicines Agency (EMA) approval of Sanofi/Regeneron's Dupixent (Dupilumab) on 03 July 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 EMA as the first biologic for uncontrolled chronic obstructive pulmonary disease (COPD) patients. 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 American Thoracic Society (ATS) conference in San Diego has shown that the agent has the potential to improve health-related quality of life, which is a plus for COPD patients.

"The EMA's approval of Dupixent has addressed a current gap in the market for COPD - the absence of biologics. The key opinion leaders (KOLs) interviewed by 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 brings a great advantage to the asset and to the COPD space, perhaps even over other biologics in the COPD pipeline.

"Dupixent is currently being used to treat patients with severe asthma, atopic dermatitis, and other eosinophilic conditions as maintenance treatment. Currently, the US Food and Drug Administration's (FDA) is yet to take decision on Dupixent's supplemental biologics license application, which was initially set for the 27 June 2024. However, it was extended three months, with a revised date of 27 September 2024. The FDA did not raise any concerns regarding the approvability of the asset.

"GlobalData's Sales and Forecast database projects total sales of Dupixent to reach $23.6 billion globally by 2030. With the EMA taking the first step of approving the first biologic for COPD and the FDA decision pending, the adoption of Dupixent for uncontrolled patients in the respiratory space will be closely watched."