Eisai: Fully Human Anti-TNFalpha Monoclonal Antibody HUMIRA Obtains Additional Approval

by JCN Newswire

TOKYO, Sep 27, 2021 - (JCN Newswire) -  AbbVie GK, Eisai Co., Ltd., and EA Pharma Co., Ltd 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-TNFalpha 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

AbbVie GK Eisai Co., Ltd. EA Pharma Co., Ltd.

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.

About HUMIRA

HUMIRA is a fully human anti-TNF-alpha monoclonal antibody. In Japan, it is approved for "the treatment of rheumatoid arthritis (including inhibition of the progression of structural damage); hidradenitis suppurativa, pyoderma gangrenosum, the treatment of plaque psoriasis, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis,* intestinal Behcet's disease, and non-infectious intermediate, posterior and panuveitis that are refractory to the conventional therapies, induction and maintenance therapy for moderate to severely active Crohn's disease (limited to patients who have had an inadequate response to conventional therapy), and treatment of moderate to severe ulcerative colitis** (limited to patients who have had an inadequate response to conventional therapy )."

(*) HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL is approved. HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL are yet to be approved
(**) HUMIRAforSubcutaneousInjection20mgSyringe0.2mLisapprovedonlyforpediatricpatients.

Nonproprietary name: Adalimumab
Brand name: Fully Human Anti-TNF-alpha Monoclonal Antibody "HUMIRA for Subcutaneous
Injection 20 mg Syringe 0.2 mL; HUMIRA for Subcutaneous Injection 40 mg Syringe 0.4 mL; HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL; HUMIRA for Subcutaneous Injection 40 mg Pen 0.4 mL; and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL"

Details of the above approval (Underlined text indicates newly approved dosage and administration)

Dosage and administration (only the section of UC is excerpted.)

Adults:

The usual initial dose of adalimumab (recombinant) is 160 mg administered by subcutaneous injection, which is followed by 80 mg administered 2 weeks after the initial
 
dose. After 4 weeks of the initial dose, 40 mg of adalimumab is subcutaneously injected once every 2 weeks. However, after 4 weeks of the initial dose, adalimumab can be subcutaneously injected at 40 mg once weekly or at 80 mg once every 2 weeks, depending on the patient's condition.

Pediatric patients:

For pediatric patients weighing 40 kg or more, the usual initial dose of adalimumab (recombinant) is 160 mg administered by subcutaneous injection, which is followed by 80 mg administered 1 week and 2 weeks after the initial dose. After 4 weeks of the initial dose, adalimumab is subcutaneously injected at 40 mg once weekly or at 80 mg once every 2 weeks.

For pediatric patients weighing 25 kg or more and less than 40 kg, the usual initial dose of adalimumab (recombinant) is 80 mg administered by subcutaneous injection, which is followed by 40 mg administered 1 week and 2 weeks after the initial dose. After 4 weeks of the initial dose, adalimumab is subcutaneously injected at 20 mg once weekly or at 40 mg once every 2 weeks.

For pediatric patients weighing 15 kg or more and less than 25 kg, the usual initial dose of adalimumab (recombinant) is 40 mg administered by subcutaneous injection, which is followed by 20 mg administered 1 week and 2 weeks after the initial dose. After 4 weeks of the initial dose, adalimumab is subcutaneously injected at 20 mg every 2 weeks.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. For more information about Eisai Co., Ltd., please visit www.eisai.com.

About EA Pharma

EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year's history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a gastrointestinal specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing.

For further information on EA Pharma Co., Ltd., please visit https://www.eapharma.co.jp/en.

(1) Australian Crohn's and Colitis Association (ACCA). The Economic Costs of Crohn's Disease and Ulcerative Colitis. 2007 Jun.
(2) Romano C, Syed S, Valenti S, Kugathasan S. Management of acute severe colitis in children with ulcerative colitis in the biologics era. Pediatrics. 2016 May; 137(5):e20151184. doi: 10.1542/peds.2015-1184.
(3) Research committee of inflammatory bowel disease, Research program on rare and intractable diseases, Health, Labour and Welfare Sciences Research Grants. For the patients of ulcerative colitis, the basic knowledge of treatments. Revised in 2020, March.
(4) Ishige T, Tomomasa T, Hatori R, et al. Temporal trend of pediatric inflammatory bowel disease: analysis of national registry data 2004 to 2013 in Japan. J Pediatr Gastroenterol Nutr. 2017; 65(4):e80-e2.
(5) Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019 Dec; 65(12):100851.

Contact Information:

AbbVie GK
Public Affairs
TEL: +81-(0)3-4577-1112

Eisai Co., Ltd.
Public Relations Department
TEL: +81-(0)3-3817-5120

EA Pharma Co., Ltd.
Corporate Planning Dept.
TEL: +81(0)3-6280-9802

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