Research & Development
The US Food and Drug Administration approves Regeneron and Sanofi's Dupixent
14 March 2019 -

The US Food and Drug Administration (FDA) has approved United States-based Regeneron Pharmaceuticals' and France-based Sanofi's Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, it was reported yesterday.

The product can be utilised with or without topical corticosteroids. It is a targeted biologic therapy that inhibits signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that are likely to play a central role in type two inflammation that underlies atopic dermatitis and several other allergic diseases. It was also granted Breakthrough Therapy designation by the US FDA for inadequately controlled moderate-to-severe atopic dermatitis in adolescents. The Breakthrough Therapy designation was created to accelerate the development and review of drugs developed for serious or life-threatening conditions.

The US FDA assessed the product application under Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions.