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Sanofi: Results Reinforce Safety Profile Of Dupixent In Children With Moderate-to-severe Asthma

The New England Journal of Medicine has published positive results from a Phase 3 Dupixent (dupilumab) clinical trial in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. The Published results reinforced well-established safety profile of Dupixent, Sanofi (SNYNF,SNY) said in a statement.

The data formed the basis for the FDA approval of Dupixent on October 20, 2021 as an add-on maintenance treatment of patients for the age group with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

The published results showed Dupixent, when added to standard of care, significantly reduced severe asthma attacks and, within two weeks, rapidly improved lung function in populations with an eosinophilic phenotype, as indicated by elevated blood eosinophils, a certain type of white blood cell, and/or with elevated fractional exhaled nitric oxide (FeNO), an airway biomarker of inflammation that plays a major role in asthma.

The results of the phase 3 trial were also included in the European regulatory filing, and a decision from the European Medicines Agency in children with uncontrolled severe asthma is expected in the first-quarter of 2022.

Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 300,000 patients have been treated globally.

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