Japan Tobacco Inc. (JT) (TSE: 2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE: 4551) announced today that JT has received manufacturing and marketing approval for CORECTIM Ointment 0.25% (generic name: delgocitinib), a Janus kinase (JAK) inhibitor, for an indication of pediatric atopic dermatitis in Japan.

In addition, JT has received approval for additional pediatric dosage and administration for CORECTIM Ointment 0.5%.

CORECTIM Ointment 0.25% and 0.5% are non-steroidal, JAK inhibitors that are expected to improve autoimmune and allergic diseases by inhibiting the action of JAKs, which play key roles in immune activation signalling in cells, by suppressing the overactivation of immune responses. In the Phase 3 comparative clinical study of CORECTIM Ointment 0.25% 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 from baseline, has met superiority to the placebo. Safety of long-term administration of CORECTIM Ointment 0.25% and 0.5% was also confirmed.

JT and Torii expect CORECTIM Ointment 0.25% and 0.5% to be a new option for the treatment of pediatric patients with atopic dermatitis in Japan. Under the terms of the agreement between JT and Torii, CORECTIM Ointment 0.25% will be sold exclusively by Torii in Japan, following its inclusion in the National Health Insurance (NHI) price list. The drugs' launch date will be announced as soon as a decision is made. CORECTIM Ointment 0.5%, the world's first topical JAK inhibitor as an indication of atopic dermatitis in adults, has been distributed in Japan by Torii since June 2020.

ABOUT Atopic Dermatitis

Atopic dermatitis is a chronic and pruritic inflammatory skin disease. It is thought to develop through exposure to various irritants or allergens for patients with a physiological abnormality of the skin (dry skin and abnormal skin barrier function).

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