▎WuXiEdited by Kant Content Team

Today, Regeneron Pharmaceuticals and Sanofi announced that they will present the results of a pooled analysis of Phase 3 trials for their jointly developed重磅 therapy Dupixent (dupilumab) in the treatment of chronic obstructive pulmonary disease (COPD) at the 2024 European Respiratory Society (ERS) Congress. The abstract results released today show,Dupixent can effectively reduce COPD exacerbations in patients.

The EU hasApprovalDupixent as an add-on maintenance treatment for patients with elevated blood eosinophils, andUncontrolledAdult patients with COPD.At that timeThe press release noted that Dupixent is the first new therapy approved in the EU for treating COPD in over a decade.At present, the U.S. FDA is targetingDupixent for the treatment of COPDA supplemental Biologics License Application (sBLA) is under review, with a PDUFA date of September 27, 2024.

Chronic obstructive pulmonary disease (COPD) is a respiratory condition and the fourth leading cause of death globally. Symptoms include persistent cough, excessive mucus production, and shortness of breath. The gradual decline in lung function can affect the ability to perform daily activities, potentially leading to sleep disturbances, anxiety, and depression. Due to recurrent acute exacerbations, systemic corticosteroid treatment and/or hospitalization may be required, imposing significant health and economic burdens on patients. Smoking and exposure to harmful particles are major risk factors for COPD, but even after quitting smoking, affected individuals may still develop or continue to suffer from the disease.

The data from the pooled analysis released this time includes the results of Dupixent in the Phase 3 clinical trials BOREAS and NOTUS. These two trials targeted COPD patients with uncontrolled symptoms who exhibited Type 2 inflammation characteristics (i.e., elevated blood eosinophils). In the trials, all patients were receiving background maximal standard-of-care inhaler therapy (nearly all patients were on triple therapy).The data from BOREAS and NOTUS were the primary data recently submitted by Dupixent for EU approval and to global regulatory authorities for the treatment of COPD patients with uncontrolled symptoms.

The pooled analysis showed that,Compared with the placebo group (n=936; p<0.0001), patients receiving Dupixent (n=938) experienced a 31% reduction in the rate of moderate or severe COPD exacerbations over 52 weeks.The meeting will announce other COPD data related to Dupixent, including indicators such as the frequency and severity of daily symptoms, impact on disease exacerbation and lung function, airflow obstruction, dyspnea, and exercise capacity.

The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. In the two COPD trials, adverse events (≥5%) that occurred more frequently with Dupixent compared to placebo were back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Dupixent is a fully humanized monoclonal antibody that inhibits signaling in the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.The U.S. FDA accepted Dupixent in February this year.The supplemental Biologics License Application (sBLA) was submitted and grantedPriority Review Status, as a patient with uncontrolled conditionCOPDAdditional Maintenance Treatment for Adult Patients。Previously, it had been approved by the FDA for the treatment of diseases including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis, and eosinophilic esophagitis (EoE).

References:

[1] Latest Dupixent® (dupilumab) and Itepekimab Data at ERS Highlight Scientific Innovation and Leadership in Respiratory Diseases. Retrieved August 26, 2024 from https://investor.regeneron.com/news-releases/news-release-details/latest-dupixentr-dupilumab-and-itepekimab-data-ers-highlight

[2] Media Update: ERS: New data highlight Sanofi’s scientific innovation and leadership in immune-mediated respiratory diseases. Retrieved August 26, 2024 from https://www.sanofi.com/en/media-room/press-releases/2024/2024-08-26-05-00-00-2935223

[3] Press Release: Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation. Retrieved August 26, 2024 from https://www.sanofi.com/en/media-room/press-releases/2024/2024-05-31-05-00-00-2891259

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