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.
Chemomab secures new patents for CM-101 monoclonal antibody
argenx receives FDA priority review for VYVGART Hytrulo in CIDP
AffaMed Therapeutics' DEXTENZA NDA accepted by Singapore regulator
AbbVie showcases gastroenterology portfolio at ECCO Congress
Japan approves Sanofi's Dupixent for chronic spontaneous urticaria
Ono partners with Shattuck Labs for bifunctional fusion proteins
Zymedi commences first in human dosage of ZMA001
Bio-Thera Solutions commences dosing in BAT6026 Phase IA/IIB clinical trial
EicOsis Human Health commences EC5026 Phase 1b multiple-ascending dose clinical trial
Takeda's HyQvia approved for maintenance therapy in CIDP patients
Celltrion USA submits CT-P47 Biologics License Application to FDA
Formosa Pharmaceuticals agrees licensing deal in Brazil for APP13007