Humira Receives Further Approval in Japan
AbbVie and Eisai announced the approval of a new indication for Humira (adalimumab), an anti-TNF-a monoclonal antibody formulation, for treating pustular psoriasis in patients exhibiting inadequate responses to conventional therapy.
The approval marks the drug’s tenth indication in Japan, and is based on the results of a phase 3 study in Japanese patients, which examined the efficacy and safety of the drug for patients diagnosed with generalized pustular psoriasis who did not respond adequately to conventional treatment.
Pustular psoriasis is categorized as an “intractable disease” by the Japanese Ministry of Health, Labor and Welfare. The disease symptoms include general illness, fever, redness, swollen limbs and pustules that cover the entire body.