FDA Delays Decision for Dupixent in COPD

The FDA has extended by three months the target action date for the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat patients with chronic obstructive pulmonary disease (COPD).

Developed by Sanofi and Regeneron Pharmaceuticals, Dupixent is being reviewed as an add-on maintenance treatment for uncontrolled COPD. The original Prescription Drug User Fee Act (PDUFA) date was June 27, 2024. The revised target action date is Sept. 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.

COPD is a respiratory disease that damages the lungs and causes progressive lung function decline. In the United States, approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation. COPD with type 2 inflammation leads to elevated blood eosinophil counts and can increase the exacerbation of the disease.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways. These pathways are believed to drive the type 2 inflammation.

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 offers 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.

The FDA has requested additional analyses on the efficacy of Dupixent in the two pivotal trials — BOREAS and NOTUS — which is considered a major amendment to the sBLA, Sanofi officials said in a news release.

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.