Saturday, September 18, 2021

FDA to review Sanofi’s Dupixent in children with uncontrolled asthma

The US Food and Drug Administration (FDA) will review Sanofi’s Dupixent as an add-on treatment for children aged six to 11 years with uncontrolled moderate-to-severe asthma.

Currently, Dupixent (dupilumab) is approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma who are aged 12 years and older, and who have elevated eosinophils or oral corticosteroid dependent asthma.

Dupixent is a monoclonal antibody (mAb) that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) – key drivers of the type 2 inflammation that plays a major role in asthma, as well as chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and eosinophilic esophagitis.

The supplemental biologics license application (sBLA) for Dupixent is supported by data that includes Phase III results evaluating Dupixent in addition to standard-of-care maintenance therapy in children with moderate-to-severe asthma with type 2 inflammation.

In the trial, Dupixent was able to significantly reduce severe asthma attacks and also rapidly improve lung function within two weeks in children aged six to 11 years.

The target action date for the FDA’s decision on Dupixent in this indication is 21 October 2021.

Sanofi is also planning an EU regulatory submission for Dupixent in this patient population in Q1 20201.

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