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September 25, 2016

US FDA accepts Sanofi and Regeneron’s dupilumab BLA for priority review

The US Food and Drug Administration (FDA) has granted priority review status to Sanofi and Regeneron’s biologics license application (BLA) for dupilumab to treat adult patients with inadequately controlled, moderate-to-severe atopic dermatitis (AD).

The US Food and Drug Administration (FDA) has granted priority review status to Sanofi and Regeneron’s biologics license application (BLA) for dupilumab to treat adult patients with inadequately controlled, moderate-to-severe atopic dermatitis (AD).

Dupilumab is a fully human monoclonal antibody developed to inhibit the interleukin-4 receptor (IL-4) alpha subunit, which blocks signalling from both IL-4 and IL-13.

IL-4 and IL-13 cytokine are required to initiate and maintain the Type 2 helper T-cell (Th2) immune response, a critical pathway in allergic inflammation.

The antibody received a breakthrough therapy designation from the FDA in 2014 to treat adults with moderate-to-severe AD who are not adequately controlled with topical prescription therapies, or for whom these treatments are not appropriate.

"IL-4 and IL-13 cytokine are required to initiate and maintain the Type 2 helper T-cell (Th2) immune response, a critical pathway in allergic inflammation."

The BLA is based on three Phase III pivotal studies data in the global LIBERTY AD programme, which evaluated dupilumab as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS).

The LIBERTY programme included more than 2,500 adult patients with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies.

Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

Sanofi and Regeneron are planning to commercialise dupilumab after receiving approval from the regulatory authorities.

Moderate-to-severe AD is a serious, chronic inflammatory skin disease, characterised by an allergic response driven by Th2 cells.

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