AbbVie GK (Headquarters: Minato-ku, Tokyo; President: James Feliciano, hereafter “AbbVie”) and Eisai Co., Ltd. (Headquarters: Tokyo; CEO: Haruo Naito, hereafter “Eisai”) today announced an approval of additional indication of HUMIRA^??(generic name: adalimumab [recombinant], hereafter “HUMIRA”), a fully human anti-TNF¦Á monoclonal antibody, for the treatment of pyoderma gangrenosum (hereafter “PG”). HUMIRA was granted orphan drug designation for the treatment of PG in 2019. This indication counts for HUMIRA¡¯s 12th indication in Japan and makes HUMIRA the world¡¯s first drug indicated for the treatment of PG.

This approval of the additional indication is based on the data from the Japanese phase III clinical trial^1?conducted in Japanese patients. This study was conducted to evaluate 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. The proportion of patients achieving at 100 (targeted PG ulcer healed) of the target pyoderma gangrenosum ulcer area reduction (PG Area Reduction: PGAR) at Week 26 of administration, which is the primary endpoint of this trial, was 54.5% (12 of 22 patients)¹. The most common adverse drug reactions in patients receiving HUMIRA were skin bacterial infection¹.

PG is an inflammatory skin disease that rapidly progresses after its onset and is classified into the following 5 types: ulcerative type, bullous type, pustular type, vegetative type, and a type that develops around a stoma².^?In ulcerative PG, the most common type, appears as painful, pustules, papules and nodules in the lower extremities, especially in the lower legs, and efferently expands to form raised ulcer lesions with infiltration on the margins³. The ulceration accompanied by intense pain and is known to cause serious effects on patients¡¯ quality of life (QOL)⁴.^?Although the pathogenic mechanism of PG is not fully understood, it is reported that approximately 20-30% of PG cases are caused by a slight injury or an external stimulus⁵.^?PG mostly affects people in their 50s to 70s, and its incidence is reported to be 3.0? per million/year in Japan⁶.

AbbVie and Eisai are committed to further contribute to the improvement of QOL of many more patients by making efforts to promote the appropriate use of HUMIRA, including its use for this indication, and to provide information on HUMIRA.

About HUMIRA

HUMIRA? is a fully human anti-TNF-¦Á monoclonal antibody. In Japan, it is approved for “the treatment of rheumatoid arthritis (including inhibition of the progression of structural damage); hidradenitis suppurativa, the treatment of plaque psoriasis, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis*, intestinal Beh?et¡¯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.

Nonproprietary name:	Adalimumab <recombinant>
Brand name:	Fully Human Anti- TNF- ¦Á 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”