FDA decision on Dupixent for COPD is expected by end of June

Therapy suppresses two molecules thought to drive type 2 inflammation

Lindsey Shapiro PhD avatar

by Lindsey Shapiro PhD |

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The U.S. Food and Drug Administration has agreed to review Sanofi and Regeneron Pharmaceuticals’ request for a label extension for Dupixent (dupilumab) to include it as an add-on treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD).

The therapy’s potential sixth indication in the U.S. is specific to COPD patients with type 2 inflammation, which is thought to contribute to lung inflammation in the disease.

The application was placed under priority review, which is granted to therapies that have the potential to provide significant improvements for treating, diagnosing, or preventing serious diseases. This shortens the agency’s standard review time from 10 to under six months. A decision is expected by June 27, according to a joint press release.

Dupixent received breakthrough therapy status from the FDA as an add-on for people with uncontrolled COPD and type 2 inflammation. The designation is meant to accelerate a therapy’s clinical development and regulatory review.

If it’s approved, Dupixent would become the only biologic therapy cleared for COPD and the first new treatment option to become available for the chronic lung disease in more than a decade, according to its developers. Biologic therapies are those that use molecules made from living organisms.

The therapy is also under review for COPD in China and Europe.

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Studies support Dupixent for COPD

The antibody-based therapy suppresses two inflammatory signaling molecules called interleukin-4 (IL-4) and interleukin-13 (IL-13) that are believed to drive type 2 inflammation, which is marked by an elevation in the blood of immune cells called eosinophils. Dupixent is approved by the FDA for five inflammatory conditions where type 2 inflammation is implicated.

Given that such inflammatory responses are also believed to be involved in COPD, its developers expect Dupixent may ease respiratory symptoms and prevent exacerbations — acute bouts of lung symptom worsening — in COPD patients who show evidence of type 2 inflammation.

That assertion is backed by data from two similarly designed Phase 3 trials — BOREAS (NCT03930732) and NOTUS (NCT04456673). Each involved more than 900 current or former smokers with COPD who had evidence of type 2 inflammation and uncontrolled disease despite standard of care inhaled therapy.

The participants received either Dupixent or a placebo as an injection under the skin, or subcutaneously, every two weeks, along with standard inhaled therapies.

Both trials met their primary goal of demonstrating that Dupixent led to significant reductions in moderate or severe COPD exacerbations over a placebo after a year of treatment. It also resulted in rapid improvements in lung function that were sustained for up to a year, meeting the trial’s key secondary goals.

The therapy’s safety profile was consistent with its known side effects in other approved indications. Side effects more common with Dupixent than a placebo in these trials included back pain, COVID-19, diarrhea, headache, and the common cold.

Sanofi and Regeneron are also codeveloping itepekimab, an antibody that’s made to block the interleukin-33 (IL-33) inflammatory molecule. Sister studies AERIFY-1 (NCT04701983) and AERIFY-2 (NCT04751487) are evaluating itepekimab’s safety and effectiveness in about 2,000 former smokers with moderate to severe COPD. Both are recruiting at sites worldwide.