FDA Approves Dupilumab as Add-On for COPD

The US Food and Drug Administration has approved dupilumab as an add-on maintenance therapy for adults whose chronic obstructive pulmonary disease (COPD) is inadequately controlled with inhaler therapy, according to a press release from manufacturer Regeneron. 
Dupilumab, a fully human monoclonal antibody sold under the brand name, Dupixent, inhibits the signaling of the interleukin 4 (IL-4) and IL-13 pathways and is the first biologic to be approved in the United States for this patient population, according to the company. The drug is administered subcutaneously every 2 weeks and is now indicated for adults with uncontrolled COPD and an eosinophilic phenotype, defined as blood eosinophil count ≥ 300 cells per microliter.
“An important proportion of patients with COPD have uncontrolled disease with frequent exacerbations and daily symptoms despite inhaled therapies,” said Diego J. Maselli, MD, University of Texas Health Science Center, San Antonio, Texas, in an interview.
“Dupilumab targets type 2 inflammation, and studies demonstrated that it decreased exacerbation rates and improved lung function in those with a history of frequent exacerbations despite triple inhaled therapy [inhaled corticosteroid, long-acting beta-2 agonist, and long-acting muscarinic antagonist],” said Maselli, who was not involved in the research for dupilumab. For these patients, dupilumab is a welcome addition to the COPD-treatment armamentarium, he said.
The approval was based on data from a pair of phase 3 studies known as BOREAS and NOTUS. The two studies included a total of 1874 adult current or former smokers aged ≥ 40 years with uncontrolled COPD and an eosinophilic phenotype. The participants were randomized to dupilumab or placebo every 2 weeks for 52 weeks, in addition to the maximum treatment with inhaled triple therapy. 
The primary endpoint was the annualized rate of moderate to severe exacerbations, and the exacerbations were significantly lower among dupilumab patients compared to placebo patients in both studies. The key secondary endpoint of forced expiratory volume in 1 second also increased significantly in patients receiving dupilumab vs placebo. Adverse events were similar between groups, and consistent with safety profiles of the drug in its other indications, according to the researchers.
“Some patients and providers may have some reservations regarding injectable therapies, particularly with regards to safety,” Maselli told Medscape Medical News. However, dupilumab has been approved for other disease states, including extensive use in asthma and atopic dermatitis, and neither the NOTUS nor BOREAS studies revealed any new safety signals in COPD when compared to placebo, he said.
Additional research is needed to evaluate the efficacy and safety of dupilumab in COPD, particularly after 12 months of therapy, and ongoing studies will help clarify these questions, Maselli noted.
Dupilumab has been previously approved to treat prurigo nodularis, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.
The dupilumab studies were funded by manufacturers Regeneron and Sanofi. Maselli had no financial conflicts to disclose but serves on the editorial board of Chest Physician. 
 
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