The European Medicines Agency (EMA) has accepted for review an application for an add-on maintenance treatment in certain adults and adolescents (12 years and older) with inadequately controlled moderate-to-severe asthma, Dupixent (dupilumab).
Asthma
Dupixent, which is being jointly developed by Sanofi and Regeneron under a global collaboration agreement, is a human monoclonal antibody specifically designed to inhibit signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13). These signalling proteins contribute to type 2 inflammation in inadequately controlled moderate-to-severe asthma.
The application for this treatment has been supported by clinical data from nearly 3,000 patients who participated in three pivotal trials, the details of which will be presented at the American Thoracic Society 2018 International Conference in May.
Furthermore, the US Food and Drug Administration (FDA) is reviewing a supplemental biologics licence application for Dupixent as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma, with a target action date of 20 October 2018.
Currently, Dupixent is approved in the European Union for use in adults with moderate-to-severe atopic dermatitis (eczema) who are candidates for systemic therapy. It is also approved in the US for the treatment of adults with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or when those therapies are not advisable. Additionally, it is approved for use in certain patients with moderate-to-severe atopic dermatitis in a number of other countries, including Canada, Japan and Australia.