FDA accepts supplemental biologics licence application for Dupixent

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application (sBLA) of Dupixent (dupilumab) for review, revealed joint developers of the drug, Regeneron and Sanofi.

This supplemental licence relates to the use of the therapy as an add-on maintenance treatment in adults with moderate-to-severe asthma.

Dupixent is a human monoclonal antibody specifically designed to inhibit signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13), which contribute to Type 2 inflammation in moderate-to-severe asthma.

The application for the supplemental use has been supported by clinical data from three trials that included 2,888 adults and adolescents. Results from two of these trials will be submitted for presentation at medical meetings later on this year.

Last year (March 2017), the FDA approved Dupixent for the treatment of adults in the US with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. It is also approved for certain patients with moderate-to-severe atopic dermatitis in a number of other countries.