Dupilumab: First Global Approval

Compliance with Ethical Standards

Disclosure: The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. M. Shirley is a salaried employee of Adis, Springer SBM.

Additional information about this AdisInsight Report can be found here.

Abstract

Dupilumab (Dupixent®) is a fully human monoclonal antibody directed against the interleukin (IL)‑4 receptor α (IL‑4Rα) subunit. Dupilumab inhibits the signalling of the type 2 cytokines IL‑4 and IL‑13 and was co-developed by Regeneron Pharmaceuticals and Sanofi as a potential therapeutic agent for the treatment of atopic or allergic diseases. In March 2017 dupilumab received its first global approval, in the USA, for use in the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab is in preregistration for this indication in the EU. In addition, dupilumab is currently under phase III development across the world for the treatment of asthma and nasal polyposis as well as for atopic dermatitis in paediatric patients. The agent has also entered phase II development in the USA for the treatment of eosinophilic oesophagitis. This article summarizes the milestones in the development of dupilumab leading to this first approval for the treatment of moderate-to-severe atopic dermatitis in adults. Access to the full article can be found here.

© Springer International Publishing AG, part of Springer Nature 2017