FDA Approves Dupixent for Patients with COPD

After a delay, the FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD). Dupixent is the first biologic approved in the United States to treat these patients.

Jean Wright, M.D.

“People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalization,” Jean Wright, M.D., CEO of The COPD Foundation, said in a news release.

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.

Developed by Sanofi and Regeneron Pharmaceuticals, 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.

This is 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.

The approval in COPD was based on two phase 3 trials evaluating the efficacy and safety of Dupixent in adults 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 most common adverse events in the two trials were more frequently seen in patients on Dupixent compared with placebo and include viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reaction, rhinitis, eosinophilia, toothache, and gastritis.

Dupixent is also being studied to treat patients with bullous pemphigoid (BP), chronic and relapsing disease, is characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning.

Earlier this month, the companies released data from the pivotal ADEPT study that showed improvements at 36 weeks in disease remission and symptoms in patients with bullous pemphigoid.