AbbVie and Eisai Announce an approval for partial changes in the marketing approval of HUMIRA®, a Fully Human Anti-TNFα Monoclonal Antibody, concerning the dosage and administration related to the indication of hidradenitis suppurativa

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 partial changes in the marketing approval of HUMIRA^® (generic name: adalimumab [recombinant], hereafter “HUMIRA”), a fully human anti- TNFα monoclonal antibody, for additional dosage and administration, specifically, to add an 80mg every-other-week (Q2W) regimen as a treatment option for patients with hidradenitis suppurativa (hereafter “HS”) after the first 4 weeks of treatment.

Previously, the recommended dose of HUMIRA for HS patients was 160 mg in week 0, followed by 80 mg two weeks later, administered by subcutaneous injection. Starting at week 4, HUMIRA should be administered at a dose of 40mg once weekly (QW). Today, a 80mg Q2W regimen has been newly added as a treatment option with efficacy and safety equivalence to those of the 40mg QW regimen. 80mg Q2W is expected to contribute to reducing patients’ burden of injection by reducing the number of administrations by half* and extend the administration interval in comparison to 40mg QW.

*When HUMIRA Subcutaneous Injection 80 mg Syringe 0.8 mL or HUMIRA Subcutaneous Injection 80 mg Pen 0.8 mL is used.

This approval was supported by the results of efficacy and safety evaluations at 80mg Q2W for HUMIRA in a Japanese phase III study (Study M15-573) and the results obtained by simulation with data in clinical pharmacokinetic studies. The Japanese phase III study was a multi-center, open-label, single-arm study to evaluate the efficacy and safety of HUMIRA in Japanese patients with moderate to severe HS.

HUMIRA was designated as an orphan drug for the indication of HS in 2017 and was approved for the first time in Japan for the indication of HS on February 21, 2019. Currently, HUMIRA is the only drug that has an indication for HS in Japan.

HS is a painful, inflammatory skin disease with a chronic course which typically presents after puberty. Inflammatory symptoms are frequently observed in the axillary, inguinal, breast-fold, and gluteal regions. The main symptom is red, swollen boil-like lumps, and the progression of symptoms leads to formation of nodules, abscesses, and even fistulas. Repeated recurrence causes thickening of the affected areas, resulting in scarring. Severe symptoms may limit the patients’ daily activities and sometimes force them to stop working. The epidemiology data in Japan is unknown, and the prevalence outside Japan is reported to be 1%. Since the disease is poorly recognized and difficult to diagnose, overseas reports indicate that the average time to definitive diagnosis is seven years, which is longer than that of psoriasis and other inflammatory skin diseases, and patients with HS visit hospitals more often.

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.