Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. announced that JT has filed a New Drug Application for JTE-052 (generic name: delgocitinib) ointment 0.25%, a Janus kinase (JAK) inhibitor, as an indication of pediatric atopic dermatitis (aged 2 to <16). In addition, JT has filed a supplemental New Drug Application for delgocitinib ointment 0.5% with the aim of an additional dosage and administration for the pediatric patients. Delgocitinib ointment was originated by JT and has been developed in Japan by JT and Torii under the terms of an agreement for co-development and marketing in Japan, signed on October 28, 2016.

Delgocitinib ointment is a non-steroidal, topical JAK inhibitor that is expected to improve autoimmune and allergic diseases by inhibiting the action of JAKs, which play key roles in immune activation signaling in cells, by suppressing the overactivation of immune responses. In the Phase 3 comparative clinical study of delgoctinib ointment in pediatric patients with atopic dermatitis (aged 2 to <16), conducted in Japan, the primary endpoint of efficacy, the percentage change of the mEASI score 1 from baseline, has met superiority to the placebo, and safety of long-term administration was also confirmed. JT and Torii expect delgocitinib ointment to be a new option for the treatment of pediatric atopic dermatitis patients in Japan.