AbbVie and Eisai Announce HUMIRA as First Treatment Approved in Japan for Hidradenitis Suppurativa
VCBeat (WeChat Official Account: vcbeat) has learned that on February 21, 2019, AbbVie and Eisai, two global leading R&D-focused biopharmaceutical companies, announced that their jointly developed drug HUMIRA (generic name: adalimumab, a fully human anti-TNF-α monoclonal antibody used for the treatment of hidradenitis suppurativa) had received approval in Japan. With this approval, HUMIRA will become the first-line therapy for hidradenitis suppurativa in Japan. Currently, HUMIRA is also approved for 11 other indications.
This approval is based on data from Phase III studies conducted in Japan and clinical trials conducted overseas. In these trials, the efficacy and safety of HUMIRA were officially evaluated in patients with moderate to severe hidradenitis suppurativa. In the clinical trial conducted in Japan, 13 out of 15 patients met the criteria for clinical response in hidradenitis suppurativa trials at Week 12 post-treatment. In the same trial, 6 out of 15 patients experienced adverse drug reactions by Week 24; more than two patients reported symptoms of nasopharyngitis and cellulitis, and one patient experienced adverse reactions including dental caries, erythema, folliculitis, increased lymphocyte count, erythema, pruritus, and skin exfoliation.
Hidradenitis suppurativa is an inflammatory skin disease that typically presents with chronic symptoms after puberty. Inflammatory lesions commonly occur in the axillae, groin, inframammary folds, and buttocks. The primary manifestations are erythematous, boil-like nodules, which can progress to form deeper nodules, abscesses, and even sinus tracts as the condition worsens. Severe symptoms can impair patients’ daily activities and sometimes render them unable to work. Due to low disease awareness and diagnostic challenges (the average time to definitive diagnosis reported abroad is seven years, longer than that for other inflammatory skin diseases such as psoriasis), patients with hidradenitis suppurativa typically require numerous medical visits.
“Hidradenitis suppurativa is a recurrent condition characterized by pain and purulent drainage, significantly impacting patients’ quality of life. In advanced cases, patients may even require extensive skin grafting surgery,” said Dr. Tadashi Terui, Professor in the Division of Dermatology, Department of Dermatology, Nihon University School of Medicine. “To date, therapeutic options for hidradenitis suppurativa have been very limited, and HUMIRA holds promise for substantially improving patients’ quality of life.”
AbbVie is a global, research-driven biopharmaceutical company dedicated to developing innovative, advanced therapies for some of the world’s most complex and serious diseases. The company’s mission is to leverage its expertise, committed workforce, and unique approach to innovation to significantly improve treatments across four core therapeutic areas: immunology, oncology, virology, and neuroscience.
Eisai is a global, research and development-driven pharmaceutical company headquartered in Japan. Eisai defines its corporate mission as “giving first thought to patients and their families, and increasing the benefits health care provides,” also known as the human health care (hhc) concept. With approximately 10,000 employees worldwide across its R&D facilities, manufacturing sites, and marketing subsidiaries, Eisai is committed to delivering a diverse portfolio of innovative products in neurology and oncology to realize the hhc concept.
(Compiled by Ning Chen)