FDA Approves Regeneron's Dupixent for COPD Treatment

Regeneron Pharmaceuticals and Sanofi have received approval from the US Food and Drug Administration (FDA) to expand the use of their drug Dupixent (dupilumab) to treat chronic obstructive pulmonary disease (COPD). This approval marks Dupixent as the first biologic available for COPD and represents its sixth approved indication.

As announced on 27 September, Dupixent will now serve as an add-on maintenance treatment for adults with inadequately controlled COPD who have an eosinophilic phenotype. Existing COPD treatments include bronchodilators like beta2-agonists and anticholinergics, standalone or combination inhaled corticosteroids (ICS), and other combination medications. Although these treatments are generally well-tolerated, the progressive nature of COPD necessitates development of maintenance therapies to complement the standard care.

The approval of Dupixent for COPD follows the failure of GSK’s anti-IL-5 antibody Nucala (mepolizumab) and AstraZeneca’s anti-IL-5 antibody Fasenra (benralizumab) to receive regulatory approval for this condition. Both companies continue to pursue the COPD label for their biologics through ongoing late-stage studies. The approval of Dupixent, however, provides a new treatment option that has the potential to improve the quality of life for patients, closing a significant gap in the US COPD treatment market, according to GlobalData Pharma analyst Asiyah Nawab.

The FDA’s approval was based on positive results from two pivotal Phase III studies named BOREAS and NOTUS. These studies assessed the safety, efficacy, and tolerability of Dupixent against a placebo in adult patients with moderate to severe COPD with type 2 inflammation. The BOREAS trial demonstrated that Dupixent reduced COPD exacerbations by 30% over 52 weeks, while the NOTUS trial showed a 34% reduction over the same period. Additionally, Dupixent was found to improve lung function at 12 weeks, with these improvements being sustained through 52 weeks. The safety profile of Dupixent in these trials was consistent with its known safety, though commonly reported adverse events in the NOTUS trial included Covid-19, nasopharyngitis, and headache.

Dupixent works as an interleukin-4 receptor alpha antagonist, inhibiting both IL-4 and IL-13. The recent FDA approval follows similar approvals in the European Union and China, where the European Medicines Agency (EMA) approved Dupixent for COPD in July, and China’s National Medical Products Administration (NMPA) granted approval on the same day as the US FDA.

Beyond COPD, Dupixent is approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic oesophagitis, and prurigo nodularis. In 2023, Dupixent generated global sales of $11.6 billion, with $8.8 billion coming from the US market. According to GlobalData’s forecasts, Dupixent is expected to achieve global sales of $23.6 billion by 2030.