Abbott Japan and Eisai have announced Humira in pre-filled syringe form as the country's first biologic agent to treat plaque psoriasis (PS) and psoriatic arthritis.
This approval marks the second indication approved for Humira, a fully human anti-TNF monoclonal antibody, after approval for rheumatoid arthritis in April 2008.
Humira is a fully human anti-TNF monoclonal antibody that neutralises TNF, a cytokine that plays a central role in inflammatory responses.
Abbott Japan is the marketing authorisation holder of Humira in Japan and Eisai is responsible for distributing the drug, while both companies have been co-promoting the drug.
A post-marketing observation survey will be conducted in all patients treated with the drug over a period of time to promote its effective and safe use in treating psoriasis.
In the clinical study conducted in 169 patients with moderate or severe PS in Japan, patients treated with Humira showed significant improvement in skin symptoms and quality of life compared to those treated with placebo.
Psoriasis is a chronic, non-communicable, inflammatory disease that is thought to involve interaction between inflammatory and skin cells, affecting around 100,000 people in Japan.