FDA delays decision on Dupixent for COPD until September

Application seeks OK for adults with uncontrolled disease, type 2 inflammation

Lindsey Shapiro PhD avatar

by Lindsey Shapiro PhD |

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The U.S. Food and Drug Administration (FDA) has delayed by three months its decision about whether to approve Dupixent (dupilumab) as an add-on treatment for certain adults with chronic obstructive pulmonary disease (COPD). A decision is now expected by Sept. 27.

An initial call was due at the end of this month, but the FDA said it needs more time to review clinical trial data submitted in May by the developers Regeneron Pharmaceuticals and Sanofi. The data, submitted at the request of the agency, were deemed a major amendment to the application.

In a press release, the developers said they’re “confident” the submitted analyses will support Dupixent’s regulatory clearance and that the FDA hasn’t raised any concerns about its ability to be approved. They said they’re “committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.”

The application seeks clearance of Dupixent for adults with uncontrolled COPD who have signs of type 2 inflammation, which is marked by an elevation in eosinophils, a type of immune cell, in the bloodstream. The cells are implicated in the lung inflammation that characterizes COPD.

Similar applications are under review in other regions, including China and the European Union. A European Medicines Agency committee recently issued a positive opinion recommending Dupixent’s approval for a patient group similar to that in the U.S. application. A decision is expected in the coming months.

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Clinical trials of Dupixent for COPD

The applications are supported by two Phase 3 trials, BOREAS (NCT03930732) and NOTUS (NCT04456673), each involving more than 900 current or former smokers with COPD. All had signs of type 2 inflammation and uncontrolled disease despite using standard inhaled therapies, which they were allowed to use during the trials.

In both studies, Dupixent, which is injected under the skin once every two weeks, was associated with significant reductions in moderate or severe COPD exacerbations compared with a placebo, meeting their main goal. Dupixent also led to rapid and sustained improvements in lung function, a key secondary aim.

The therapy’s safety was consistent with its known side effect profile. The most common adverse events that occurred at higher rates in the Dupixent group included back pain, COVID-19 infection, diarrhea, headache, and cold-like symptoms.

Last month, the FDA asked the developers to provide additional data related to certain subgroup analyses from the trial by the end of May. At the time, Dupixent’s developers indicated the findings from those analyses supported the therapy’s benefits and would be submitted before the deadline.

Dupixent is a biological therapy, that is, one made from living organisms, that’s designed to suppress two inflammatory molecules believed to drive type 2 inflammation.

It’s approved in the U.S. for five other indications marked by that type of inflammation and holds breakthrough therapy status from the FDA as an add-on treatment for uncontrolled COPD with type 2 inflammation. The status is meant to speed its clinical development and review.

Should Dupixent be approved for COPD in the U.S. and Europe, it will become the first new treatment for the serious lung disease in more than a decade.