Dupixent Demonstrates Efficacy Treating Chronic Obstructive Pulmonary Disease, Asthma

Image Credit: Adobe Stock Images/Lila Patel

Updated results from Regeneron and Sanofi’s Phase III BOREAS and NOTUS trials show the efficacy of Dupixent (dupilumab) in targeting type 2 inflammation and other pathways in conditions such as chronic obstructive pulmonary disease (COPD) and asthma. These data, as well as several other abstracts including the investigational therapy itepekimab, will be presented at the European Respiratory Society (ERS) Congress 2024, showcasing advancements in respiratory disease management.¹

“The breadth of our presentations at the ERS Congress showcase our commitment to advancing the management of a range of difficult-to-treat respiratory diseases,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, principal inventor of Dupixent, in a press release. “Through our Dupixent clinical program, we have gained a deep understanding of the biology of airway diseases. We are now applying those insights to COPD, a complex and heterogenous disease, and are excited by the remarkable potential of our COPD research program investigating Dupixent, as well as our anti-IL-33 antibody itepekimab to support COPD patients regardless of smoking history."

Results from the BOREAS and NOTUS trials demonstrated that Dupixent reduced moderate-to-severe COPD exacerbations by 31% over 52 weeks. Common adverse events (AEs) of the trials that were more consistent than in the placebo group included back pain, COVID-19, diarrhea, headache, and nasopharyngitis. Further COPD data that will be presented at ERS will evaluate the impact of Dupixent on daily symptom frequency and severity, exacerbations and lung function regardless of baseline body mass index, airflow obstruction, dyspnea, and exercise capacity measures.

Additionally, research from the Phase IV VESTIGE trial, which is currently evaluating the efficacy of Dupixent on airway remodeling in certain adults with asthma, will be presented through two poster presentations demonstrating the four-week impact of Dupixent treatment on airway inflammation, volume and flow, and mucus plugging, as well as outcomes for clinical remission after four and 24 weeks of treatment in adults with uncontrolled moderate-to-severe asthma.¹

Back in February, the FDA granted Priority Review status to a supplemental Biologics License Application (sBLA) for Duplixent as add-on maintenance therapy for adults with uncontrolled COPD with type 2 inflammation. Submission was based on results of the aforementioned BOREAS and NOTUS trials, which consisted of 1,874 patients showing evidence of type 2 inflammation, as measured by blood eosinophils ≥300 cells per µL. The primary endpoint for both trials was the annualized rate of acute moderate or severe COPD exacerbations. At the time, the Prescription Drug User Fee Act (PDUFA) date was June 27, 2024.^2,3

“This is the first and only time an investigational biologic in COPD has shown a significant and clinically meaningful reduction in exacerbations in two Phase III trials and we are pleased that we can potentially deliver Dupixent faster to patients in need where no new advancements have been identified in over a decade,” former Sanofi Head of Global Development, Immunology and Inflammation Naimish Patel, MD, said in a press release. “These data validate our belief that Dupixent has the potential to transform the treatment of moderate-to-severe COPD and given the significant unmet needs for patients with uncontrolled COPD, we are not stopping with Dupixent. Our second program in COPD, itepekimab, continues with data expected in 2025. If positive, Dupixent and itepekimab could emerge as treatments for approximately 80% of those suffering from moderate-to-severe COPD with recurrent exacerbations.”⁴

In late May, the FDA extended PDUFA date by three months, resulting from a request for additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials. As a result, the agency stated that this additional information constituted a major amendment to the sBLA and extended the target action date, now scheduled for September 27, 2024.⁵

References

1. LATEST DUPIXENT® (DUPILUMAB) AND ITEPEKIMAB DATA AT ERS HIGHLIGHT SCIENTIFIC INNOVATION AND LEADERSHIP IN RESPIRATORY DISEASES. Regeneron. August 26, 2024. Accessed August 26, 2024. https://investor.regeneron.com/news-releases/news-release-details/latest-dupixentr-dupilumab-and-itepekimab-data-ers-highlight

2. FDA Grants Priority Review to Dupixent for Uncontrolled Chronic Obstructive Pulmonary Disease. Pharm Exec. February 23, 2024. Accessed August 26, 2024. https://www.pharmexec.com/view/fda-grants-priority-review-to-dupixent-for-uncontrolled-chronic-obstructive-pulmonary-disease

3. Dupixent® (Dupilumab) sBLA Accepted For FDA Priority Review For Treatment Of COPD With Type 2 Inflammation. Regeneron. News release. February 23, 2024. Accessed August 26, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-priority-review-treatment

4. DUPIXENT® (DUPILUMAB) SIGNIFICANTLY REDUCED COPD EXACERBATIONS IN SECOND POSITIVE PHASE 3 TRIAL, ACCELERATING FDA SUBMISSION AND CONFIRMING POTENTIAL TO BECOME FIRST APPROVED BIOLOGIC FOR THIS SERIOUS DISEASE. Regenron. November 27, 2023. Accessed August 26, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-significantly-reduced-copd-exacerbations

5. UPDATE ON FDA PRIORITY REVIEW OF DUPIXENT® (DUPILUMAB) FOR THE TREATMENT OF COPD PATIENTS WITH TYPE 2 INFLAMMATION. Regeneron. May 31, 2024. Accessed August 26, 2024. https://investor.regeneron.com/news-releases/news-release-details/update-fda-priority-review-dupixentr-dupilumab-treatment-copd