Shots:

• The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment- or who were judged to be unsuitable for local treatment
• Result: The proportion of patients achieving at 100 (targeted PG ulcer healed) of the target PGAR @26wks. of administration (54.5%)
• The indication marks Humira’s 12th indication in Japan and making it the world’s first drug indicated for the treatment of PG. Humira has received MHLW’s ODD for the treatment of PG in 2019

 ­ Ref: Eisai | Image: abbvie