Potential First! Dupixent to Submit Regulatory Application by Year-End, Significantly Reducing COPD Exacerbations

▎Edited by the WuXi AppTec content team

Today, Sanofi and Regeneron jointly announced重磅IL-4/IL-13 inhibitorDupixent Achieves Primary Endpoint in Second Phase 3 Clinical Trial for COPD, Significantly Reducing Disease Exacerbation in Moderate to Severe COPD PatientsBased on this result, the two companies plan to submit a supplemental Biologics License Application (sBLA) to the U.S. FDA before the end of the year. The press release noted,Dupixent is expected to become the first approved biologic for treating this serious disease.

The Phase 3 trial, named NOTUS, included 935 adults aged 40 to 85 years who were either current or former smokers. They were randomly assigned to receive Dupixent (470 participants) or a placebo (465 participants) in addition to the existing maximal standard inhaled therapy. The main findings of the trial indicated that, compared with the placebo, patients treated with Dupixent:

Moderate or severe COPD exacerbations were significantly reduced by 34% (p=0.0002) within 52 weeks, which was the primary endpoint of the study.

。

Lung function improved by 139 mL from baseline at 12 weeks, compared to only 57 mL in the placebo group (p=0.0001). This advantage was maintained at week 52 compared to placebo, with the Dupixent group showing an improvement of 115 mL versus only 54 mL in the placebo group (p=0.0182).

The safety of Dupixent in this trial is generally consistent with its known safety profile in previously approved indications. The overall incidence of adverse events (AEs) was very similar, with 67% in the Dupixent group and 66% in the placebo group. AEs observed more frequently in the Dupixent group (incidence ≥5% and a difference ≥1% compared to placebo) included COVID-19 (Dupixent 9.4%, placebo 8.2%), nasopharyngitis (Dupixent 6.2%, placebo 5.2%), and headache (Dupixent 7.5%, placebo 6.5%). The incidence of AEs leading to death was 2.6% in the Dupixent group and 1.5% in the placebo group.

Dupixent is a fully humanized monoclonal antibody that inhibits signaling in the interleukin-4 and interleukin-13 pathways.Previously, dupilumab has 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).

[1] 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. Retrieved November 27, 2023, from https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-significantly-reduced-copd-exacerbations

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