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Fully Human Anti-TNFα Monoclonal Antibody HUMIRA® Obtains Additional Approval for High-Dose Regimen of Ulcerative Colitis in Adult Patients and for New Regimen in Pediatric Patients

AbbVie GK (Headquarters: Tokyo, President: James Feliciano, "AbbVie"), Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), and EA Pharma Co., Ltd. (Headquarters: Tokyo, CEO: Yuji Matsue, "EA Pharma") announced today the additional approval for a high-dose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients regarding fully Human Anti-TNFα Monoclonal Antibody HUMIRA® (generic name, adalimumab [recombinant]; “HUMIRA”) .

This approval allows for 40 mg weekly treatment or 80 mg biweekly treatment in addition to conventional 40 mg biweekly treatment as a remission maintenance therapy, which is expected to maintain remission in many patients. Furthermore, by having been added as a treatment option for ulcerative colitis in pediatric patients, it is expected that as the first at-home/self-injectable drug in Japan for pediatric patients with ulcerative colitis, HUMIRA will improve convenience for pediatric patients and their guardians in addition to reducing burdens due to hospital visits.

Ulcerative colitis (UC) is designated as an intractable disease in Japan. It is characterized by intestinal inflammation of unknown cause and subsequent damage to the colonic mucosa that results in erosion (a sore lesion) or ulceration. Patients with UC experience chronic diarrhea and hematochezia, abdominal pain, fever, anemia, etc. These symptoms resolve (remission) and flare up (relapse) repeatedly. It remains a long-term condition that is not adequately controlled in some patients; more treatment options are needed.1,2 Although the etiology of UC is still unclear, it may be associated with abnormalities in the immune system that protects the body from bacteria and other foreign substances. About 220,000 people suffer from UC in Japan and the number is increasing year by year.3 Many patients receive a diagnosis of UC in their late 10s to early 30s. The disease rarely develops in childhood, with an estimated prevalence in Japan of 15 per 100,000 between the ages of 0 to 19.4

In both adults and pediatric patients, the goal of treatment for UC is achieving long-term maintenance of remission with drug treatment. However, total colectomy may eventually be required in 30% of patients with severe UC. 5

In Japan, AbbVie is the marketing and manufacturing authorization holder for HUMIRA. Abbvie and Eisai are co-promoting HUMIRA for the indications in the fields of rheumatoid arthritis, plaque psoriasis, arthropathic psoriasis, ankylosing spondylitis, juvenile idiopathic arthritis, uveitis, pustular psoriasis, hidradenitis suppurativa and pyoderma gangrenosum. For the indications in the field of gastrointestinal disease (i.e., Crohn’s disease, intestinal Bechet’s disease and ulcerative colitis), AbbVie is co-promoting HUMIRA with EA Pharma, commissioned by Eisai for promotion.

AbbVie, Eisai and EA Pharma are committed to make a further contribution to treatment for patients with autoimmune diseases through providing more treatment options to adult and pediatric patients with UC. 

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Last Updated: 27-Sep-2021