Regeneron, Sanofi: EU Approves Dupixent For Children Aged 6 To 11 Years With Severe Asthma

Regeneron Pharmaceuticals, Inc. (REGN), and French drug maker Sanofi (SNYNF,SNY) announced Thursday that the European Commission has expanded the marketing authorization for Dupixent (dupilumab) in the European Union.

Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide or FeNO, who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

Asthma is one of the most common chronic diseases in children, and majority of them may have type 2 inflammation and are more likely to have higher disease burden.

Dupixent, which was invented using Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Dupixent is an injection under the skin, i.e., subcutaneous injection, at different injection sites.

The EU approval is based on data from the Phase 3 VOYAGE trial showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children.

The primary endpoint was the annualized rate of severe asthma exacerbations over one year, and the key secondary endpoint was the change from baseline in percentage of predicted pre-bronchodilator FEV1 (FEV1pp) at week 12.

The companies said they continue to investigate Dupixent in other conditions where type 2 inflammation may significantly impact patients' lives, including eosinophilic esophagitis, prurigo nodularis and chronic spontaneous urticaria.

Dupixent is also approved in Europe, U.S., Japan and other countries around the world for use in certain patients with asthma, specific patients with moderate-to-severe atopic dermatitis as well as 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 400,000 patients have been treated globally.

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