FDA Grants Priority Review to Dupixent in COPD

The FDA has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024.

If approved, this would be the sixth indication for Dupixent and the only biologic therapy for COPD. Dupixent is also approved to treat eosinophilic esophagitis, moderate-to-severe atopic dermatitis, moderate-to-severe asthma, chronic rhinosinusitis with nasal polyposis and the rare skin disease prurigo nodularis.

Dupixent, developed by Regeneron Pharmaceuticals and Sanofi, is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways. The list price of Dupixent is $3,803.20 per carton. For commercial patients, Sanofi offers a $0 copay card with an annual limit of $13,000. The company also offer patient assistance for those who qualify.

The application for the COPD indication is based on data from two phase 3 trials evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of type 2 inflammation. The primary endpoint was met in both trials, showing Dupixent reduced annualized moderate or severe acute COPD exacerbations by 30% in one trial and 34% in the second trial, compared with placebo. In both trials, Dupixent improved lung function compared with placebo, with improvements sustained at 52 weeks.

Adverse events more commonly seen with Dupixent were back pain, COVID-19, diarrhea, headache and nasopharyngitis.

Sanofi and Regeneron are studying Dupixent in other diseases driven by type 2 inflammation or other allergic processes, including chronic spontaneous urticaria (hives), chronic pruritus (itching) of unknown origin and the rare skin condition bullous pemphigoid.

Additionally, the companies are developing a separate human monoclonal antibody — itepekimab — that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD.