Pharmaceutical Technology

Dupixent gets closer to EU approval as the FDA delays its decision on COPD

The CHMP has given a positive recommendation to Dupixent for COPD while the FDA has delayed its verdict from June to September.

Sanofi and Regeneron’s blockbuster drug Dupixent (dupilumab) is nearing approval for a new indication, as it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for chronic obstructive pulmonary disease (COPD).

CHMP gave a positive recommendation on the approval of Dupixent as an add-on maintenance treatment in Europe for certain adult patients with uncontrolled COPD. If approved, it would be the first biologic approved to treat the indication in the EU. The European Commission is expected to announce a final decision in the coming months.

In contrast, the US Food and Drug Administration (FDA) has delayed the timeline for its verdict on the COPD indication from 27 June to 27 September. The delay was after the companies submitted additional analyses on the efficacy of Dupixent as an add-on treatment in COPD patients following an FDA request for the same. The agency granted priority review for a supplemental biologics licence application (sBLA) for Dupixent back in February 2024.

Already approved to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis, Dupixent has demonstrated efficacy in Phase III trials against COPD. In the NOTUS (NCT04456673) and BOREAS (NCT03930732) trials, Dupixent reduced the rate of exacerbations or attacks compared to placebo when added to standard therapies like bronchodilators, inhaled or oral corticosteroids to reduce inflammation in the lungs, and mucolytics to reduce phlegm.

COPD is a progressive lung disease that causes shortness of breath, a chronic cough, and mucus production. GlobalData epidemiologists estimate there are over 138.6 million cases of COPD worldwide.

Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. According to GlobalData’s Pharma Intelligence Center, Dupixent generated $11.3bn in 2023 and is forecast to make $23bn by 2030.

GlobalData is the parent company of Pharmaceutical Technology.

Dupixent has also had a setback in chronic spontaneous urticaria (CSU). The FDA rejected the sBLA for the therapy in October 2023, stating that more efficacy data was needed to support Dupixent’s approval in CSU. However, Sanofi and Regeneron plan to resubmit the sBLA, supported by data from the Phase III LIBERTY-CUPID Study C trial (NCT04180488). Results from the trial are expected in late 2024.