Japan Tobacco : JT Receives Manufacturing and Marketing Approval of CORECTIM Ointment 0.5% for the Treatment of Atopic Dermatitis in Japan

Japan Tobacco Inc. (JT) (TSE: 2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE: 4551) announced that JT has today received manufacturing and marketing approval for CORECTIM Ointment 0.5% (generic name: delgocitinib), a Janus kinase (JAK) inhibitor, for an indication of atopic dermatitis in Japan.

JT filed a New Drug Application (NDA) for the drug on January 31, 2019.

CORECTIM Ointment 0.5% is a non-steroidal topical product and the world's first topical JAK inhibitor that improves atopic dermatitis by inhibiting the action of JAKs, which play a key role in immune activation signaling in cells, by suppressing the overactivation of immune responses. In the Phase 3 comparative clinical study in patients with atopic dermatitis (aged 16) for CORECTIM Ointment 0.5%, conducted in Japan, the primary endpoint of efficacy, the percentage change of the mEASI score from baseline, has met superiority to the placebo. Furthermore, CORECTIM Ointment 0.5% demonstrated a favorable safety profile in long-term treatment.

JT and Torii expect CORECTIM Ointment 0.5% to be a new option for the treatment of atopic dermatitis patients in Japan. Under the terms of the agreement on October 2016 between JT and Torii, the drugs 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.

Also, the Phase 3 clinical study in pediatric patients with atopic dermatitis (aged 2 to

Outline of approval

Product Name: CORECTIM Ointment 0.5%

Generic Name: Delgocitinib

Indications: Atopic Dermatitis

Dosage and Administration: For adults, apply an appropriate amount of ointment to the affected areas twice daily. The dose applied should not exceed 5 g per dosing.

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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