FDA Approves Dupilumab (Dupixent) for Treatment of COPD

Regeneron has announced the US Food and Drug Administration (FDA) approval of dupilumab (Dupixent) for individuals with chronic obstructive pulmonary disease (COPD).¹

Announced on September 27, 2024, the FDA’s decision, which is based on data from the BOREAS and NOTUS trials, comes less than 4 months after the organization extended the original target action date for Regeneron and Sanofi’s Biologics License Application for dupilumab as an add-on treatment in patients with uncontrolled COPD.

“This latest FDA approval for (dupilumab) represents new hope for the hundreds of thousands of COPD patients in the U.S. who can sometimes struggle just to breathe during their everyday lives,” George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, and principal inventor of dupilumab, said in a statement. “...This latest approval represents an important next chapter for (dupilumab), giving those with COPD a novel option that has demonstrated the unprecedented ability to help patients experience fewer exacerbations, while also helping them breathe better and improve quality of life in Phase 3 trials.”¹

Billed as the first FDA approved biologic to target interleukin (IL)- 4 and 13 inhibitor, dupilumab has carved a a role for itself in multiple conditions as trial after trial have elucidated its role in the management of type 2 inflammation among those with atopic or allergic conditions.

The originally assigned target action date for dupilumab in uncontrolled COPD was June 2024, but the FDA requested additional data from the pivotal BOREAS and NOTUS studies.² With the latest approval, dupilumab now boasts more than a dozen approvals from the FDA, including indications as either an add-on or primary therapy for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, or eosinophilic esophagitis.

The FDA decision followed positive results drawn from the BOREAS and NOTUS trials, both of which evaluated dupilumab’s efficacy and safety profile among individuals with high exacerbation risk and evidence of type 2 inflammation as measured by blood eosinophil counts greater than or equal to 300 cells per microliter. These individuals had also been on triple inhaled therapy.³

The sBLA is supported by data from the landmark BOREAS and NOTUS phase 3 trials evaluating the efficacy and safety of dupilumab in adults who were current or former smokers with uncontrolled COPD with type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL). All subjects involved were on background maximal standard-of-care inhaled therapy (nearly all on triple therapy).

Both studies met their primary endpoints, with dupilumab treatment leading to significant reductions in annualized moderate or severe acute exacerbations of COPD by up to 34%, compared to those in the placebo arm. The drug also led to rapid improvements in participants’ lung function versus placebo, and these improvements continued to 52 weeks.⁴

The investigators also noted that the drug’s safety findings were consistent in both BOREAS and NOTUS with dupilumab’s safety profile for its indications. Back pain, headaches, COVID-19 infections, and nasopharyngitis were among the adverse events more commonly seen with those treated (≥5%) versus those given a placebo in either trial.⁴

In June 2023, Regeneron and Sanofi announced the European Medicines Agency approved dupilumab as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils.³

“With today’s approval, (dupilumab) once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations," Paul Hudson, chief executive officer at Sanofi, said in a statement.¹

References

1. ^{Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD. Regeneron Pharmaceuticals, Inc. September 27, 2024. https://www.globenewswire.com/news-release/2024/09/27/2954552/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-ever-Biologic-Medicine-for-Patients-with-COPD.html. Date accessed: September 27, 2024.}
2. ^{Kunzmann K. FDA Extends Dupilumab COPD Decision to September 2024. HCPLive. May 31, 2024. https://www.hcplive.com/view/fda-extends-dupilumab-copd-decision-september-2024. Date accessed: September 23, 2024.}
3. ^{Smith T. Surya Bhatt, MD: Findings on Dupilumab for Patients with COPD, Type 2 Inflammation. HCPLive. February 27, 2024. https://www.hcplive.com/view/surya-bhatt-findings-on-dupilumab-for-patients-with-copd-type-2-inflammation. Date accessed: September 23, 2024.}
4. ^{Regeneron. UPDATE ON FDA PRIORITY REVIEW OF DUPIXENT® (DUPILUMAB) FOR THE TREATMENT OF COPD PATIENTS WITH TYPE 2 INFLAMMATION. Press release. Published May 31, 2024. https://investor.regeneron.com/news-releases/news-release-details/update-fda-priority-review-dupixentr-dupilumab-treatment-copd.}