by Lori Solomon

The U.S. Food and Drug Administration has approved Regeneron's Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

The approval was based on results from two pivotal Phase III trials (BOREAS and NOTUS) that evaluated Dupixent (468 and 470 participants, respectively) compared to placebo (471 and 465 participants, respectively) in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy) with inadequately controlled COPD and blood eosinophils ≥300 cells per μL.

Dupixent was associated with a 30 and 34 percent reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks (the primary end point) versus placebo. Greater improvements in postbronchodilator forced expiratory volume in the first second from baseline at week 12 were also seen with Dupixent (74 mL and 68 mL versus placebo) and were sustained at 52 weeks.

Safety results were generally consistent with the known safety profile of Dupixent. Cholecystitis was seen in 0.6 percent of patients on Dupixent versus 0.1 percent of patients on placebo.

"This latest FDA approval for Dupixent represents new hope for the hundreds of thousands of COPD patients in the United States who can sometimes struggle just to breathe during their everyday lives," George D. Yancopoulos, M.D., Ph.D., the president and chief scientific officer at Regeneron and a principal inventor of Dupixent, said in a statement.

"Dupixent has a proven track record as a first-in-class medicine, providing benefit to the many patients suffering from type 2 inflammatory related diseases such as asthma and atopic dermatitis."

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