▎WuXiEdited by Kant Content Team

Today, Regeneron Pharmaceuticals and Sanofi announced that the U.S. FDA has approved the expansion of the indication for their jointly developed重磅 therapy Dupixent (dupilumab) as a maintenance treatment for patients with poorly controlled chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype. The press release noted that this isFDA Approves First Biologic Therapy for COPD Treatment.Dupixent was also approved on September 27Approved by the National Medical Products Administration (NMPA) of China，For the treatment of adult COPD patients with elevated blood eosinophils and poor symptom control.

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 may affect the ability to perform daily activities, leading to sleep disturbances, anxiety, and depression. Due to recurrent acute exacerbations, systemic corticosteroid treatment and/or hospitalization are often required, imposing significant health and economic burdens on patients. Smoking and exposure to harmful particles are the primary risk factors for COPD.

FDA Approval Based on Positive Results of Dupixent in BOREAS and NOTUS Phase 3 Clinical TrialsThe FDA's approval is mainly based on the positive results obtained by Dupixent in the BOREAS and NOTUS Phase 3 clinical trials. 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 received the maximum dose of standard inhaled therapy (almost all patients were on triple therapy).

The previously released pooled analysis data indicates 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 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.Previously, it had been approved by the FDA for the treatment of various diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis, and eosinophilic esophagitis (EoE). This yearJuly,European Medicines Agency (EMA) ApprovalDupixentAs an add-on maintenance treatment drug, used to treat conditions characterized by elevated blood eosinophils, andUncontrolledAdult patients with COPD.

References:

[1] Dupixent approved in the US as the first-ever biologic medicine for patients with COPD. Retrieved September 27, 2024, from https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-27-13-35-00-2954551

[3] 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

[4] 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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