Japan approval for JT and Torii's Corectim for atopic dermatitis

Japan Tobacco (TSE:2914) and Torii Pharmaceutical (TSE:4551) have received manufacturing and marketing approval for Corectim Ointment 0.5% (delgocitinib; formerly JTE-052), a Janus kinase (JAK) inhibitor, for an indication of atopic dermatitis in Japan. JT, a tobacco firm with a small pharmaceuticals division, 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 III 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.