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AbbVie, Eisai, and EA Pharma Obtain Additional Approval for New Dosing Regimen of Fully Human Anti-TNF Monoclonal Antibody Humira in Patients with Crohn's Disease.

TOKYO, June 20, 2016 - (JCN Newswire) - AbbVie GK (Headquarters: Tokyo, President: James Feliciano, "AbbVie"), Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), and its subsidiary EA Pharma Co., Ltd. (Headquarters: Tokyo, CEO: Hajime Shimizu, "EA Pharma") today announced the additional approval for a new dosing regimen of Humira Pre-filled Syringe 40 mg/0.8 mL for Subcutaneous Injection (generic name: adalimumab[recombinant], "Humira"), a fully human anti-TNF monoclonal antibody formulation, in patients with moderate or severe Crohn's disease who become less responsive to treatment with 40 mg every two weeks to double the dose to 80 mg every two weeks.

The usual adult dose of Humira for Crohn's disease is: initial dose of 160 mg of adalimumab (recombinant) given subcutaneously (SC) followed by 80 mg SC two weeks after the initial dose, then after four weeks of the initial dose. Thereafter, 40 mg SC is given every two weeks. However, some patients became less responsive during their course of treatment, necessitating therapy aimed at "longterm maintenance of remission" which is the goal of treatment for Crohn's disease.

Recently, a Japanese clinical study demonstrated the efficacy of an increased dose of 80 mg every two weeks in patients who become less responsive to the conventional dose. As a result, an additional approval was granted for a change in dosing regimen for these patients.

The Japanese Clinical Study on which the present approval was granted was conducted at 12 trial sites with 28 patients suffering from moderate or severe Crohn's disease who became less responsive to treatment with 40 mg every two weeks. This study was a 52-week open-label study to assess the efficacy and safety of Humira when increased to 80 mg every two weeks in which the primary efficacy evaluation

was performed at Week 8. When compared to before dose increase, the percentage of patients who experienced a decrease of 50 or greater in Crohn's Disease Activity Index (CDAI) score was 75.0% at Week 8 of treatment, showing an immediate benefit following dose increase. The benefit was maintained for a long period with the percentage of patients with improved CDAI score being 71.4% at Week 24 and 57.1% at Week 52 of treatment. As for the safety of the increased dose of Humira, the safety profile was comparable to dose observed for conventional treatment with Humira; the increased dose was also well tolerated.

In Japan, AbbVie is the marketing and manufacturing authorization holder for HUMIRA. For the indications in the field of gastrointestinal disease (i.e., ulcerative colitis, Crohn's disease, and intestinal Bechet's disease), AbbVie and EA Pharma, a subsidiary of Eisai, are co-promoting Humira. Abbvie and Eisai are co-promoting Humira for the indications in the fields other than gastrointestinal disease (i.e., rheumatoid arthritis, plaque psoriasis, arthropathic psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis).

AbbVie, Eisai and EA Pharma will continue to promote and provide information on the proper use of HUMIRA while making further contributions to improve the quality of life of patients.

About Humira

HUMIRA is a fully human anti-TNF-alpha monoclonal antibody which is approved for the following indications in Japan: "treatment of rheumatoid arthritis (including prevention of structural joint damage) and the following diseases that do not sufficiently respond to existing treatments: psoriasis vulgaris; arthropathic psoriasis; ankylosing spondylitis; polyarticular juvenile idiopathic arthritis; intestinal Behcet's disease; moderate to severe active Crohn's disease as remission induction and maintenance therapy; and moderate to severe ulcerative colitis."

[Information being added is indicated by underlining.]

Brand name:

Humira Pre-filled Syringe 40 mg/0.8 mL for Subcutaneous Injection

Generic name:

Adalimumab (recombinant)

Indications:

Induction and maintenance of remission in patients with moderate or severe active Crohn's disease (only when conventional treatments are poorly effective)

Dosage and administration:

The initial dose of Humira is usually given subcutaneously as 160 mg of adalimumab (recombinant) followed by 80 mg two weeks after the first dose and after four weeks of the initial dose. Thereafter, 40 mg is given subcutaneously every two weeks.

The dose can be increased to 80 mg every two weeks when the patient becomes less responsive.

About Crohn's disease

Crohn's disease (CD) is an inflammatory disease characterized by ulcers and/or inflammatory lesions in the gastrointestinal tract and is associated with repeated flares/relapses over its long course; CD is most commonly seen in adolescents in their 10s to 20s.(1) The number of CD patients in Japan is increasing every year, from 128 patients in 1976 to 29,799 in 2013.(1)

About CDAI

CDAI stands for Crohn's Disease Activity Index and is a measure for evaluating the disease activity of Crohn's disease. The items from which CDAI score is derived include number of soft stools or diarrhea over the last week, intensity of abdominal pain, and subjective general well-being as well as presence of

complications with Crohn's disease, hematocrit, and body weight. CDAI score of 220 to 450 corresponds to moderate to severe disease.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

About AbbVie GK

AbbVie GK was established in Japan in 2013. The company employs 1,000 people, dedicated to developing and delivering treatments in our therapeutic areas focused on immunology, neonatology, liver disease and neuroscience, where we believe we can make a remarkable impact on the lives of patients. For further information, please visit www.abbvie.co.jp .

About EA Pharma

Established in April 2016 through the integration of Eisai's gastrointestinal disease business and AJINOMOTO PHARMACEUTICALS Co., Ltd., EA Pharma is a gastrointestinal specialty pharma with a full value chain including research and development, production and logistics, sales and marketing.

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

About Eisai

Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.

Source: Eisai

Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120


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Publication:JCN Newswires
Geographic Code:9JAPA
Date:Jun 20, 2016
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