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April 8, 2022

EC approves Sanofi and Regeneron’s Dupixent for severe asthma in children

The expanded authorisation is based on findings from the Phase III VOYAGE trial of Dupixent.

The European Commission (EC) has updated the marketing authorization for Sanofi and Regeneron’s Dupixent (adupilumab) to include as an add-on maintenance treatment for severe asthma with type 2 inflammation in children of the age six to 11 years. 

The treatment is intended for such patients with type 2 inflammation characterised by increased blood eosinophils and/or elevated fractional exhaled nitric oxide (FeNO).

Children who are not controlled well following treatment with medium to high dose inhaled corticosteroids (ICS) plus another therapy as maintenance treatment can receive Dupixent.

A fully human monoclonal antibody, Dupixent is not an immunosuppressant and hinders the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. 

The latest expanded authorisation is based on pivotal findings from the double-blind, randomised, placebo-controlled Phase III VOYAGE clinical trial.

It is designed to assess the safety and efficacy of Dupixent plus standard-of-care asthma treatment in 408 children with uncontrolled moderate-to-severe asthma.

Trial findings showed that Dupixent substantially lowered severe asthma attacks, boosted lung function and the health-associated quality of life in children.

Furthermore, the safety data from the trial was in line with the already known safety profile of the antibody in individuals of the age 12 years and above with uncontrolled moderate-to-severe asthma. 

Sanofi Immunology and Inflammation Global Development head Naimish Patel said: “We are excited to bring the well-established safety and efficacy of Dupixent to even younger patients living with uncontrolled severe asthma in Europe. 

“In addition to greatly reducing severe asthma attacks and improving lung function, patients in our clinical trial also reduced their oral corticosteroid use.”

In October 2019, Dupixent received EC approval for the treatment of severe chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults.

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