AbbVie and Eisai Announce Humira as World’s First Approved Treatment for Pyoderma Gangrenosum in Japan

November 29, 2020 /BioonBIOON/ -- AbbVie and Eisai recently announced jointly that Humira (generic name: adalimumab) has been approved in Japan for a new indication to treat pyoderma gangrenosum (PG).

This approval makes Humira the first drug worldwide for the treatment of PG. To date, Humira has been approved for 12 indications in Japan. In 2019, Humira was granted Orphan Drug Designation (ODD) for the treatment of PG.

This approval is based on a Japanese Phase 3 study conducted in patients in JapanClinical Trialdata. The study was conducted inDiagnosisConducted in patients with pyoderma gangrenosum (PG), active ulcers, inadequate response to topical therapy, or those deemed unsuitable for topical therapy, this study aimed to evaluate the efficacy and safety of Humira. The results showed that the study met its primary endpoint: at Week 26, 54.5% (n=12/22) of patients achieved a 100% reduction in pyoderma gangrenosum ulcer area (PGAR) (target PG ulcer healing). In this study, among patients treated with Humira, the most common drug-Adverse ReactionsIt is the skin.BacteriaInfection.

Pyoderma Gangrenosum (Image source: learnskin.com)

Pyoderma gangrenosum (PG) is an inflammatory dermatosis that progresses rapidly after onset and is classified into the following five types: ulcerative, bullous, pustular, vegetative, and peristomal. Ulcerative PG is the most common type, characterized by painful pustules, papules, and nodules on the lower extremities, which actively expand to form raised ulcerative lesions with undermined, infiltrated borders. The ulcers are associated with severe pain, significantly impairing patients' quality of life.

Although the pathogenesis of pyoderma gangrenosum (PG) is not fully understood, it has been reported that approximately 20–30% of PG cases are triggered by minor trauma or external stimuli. PG primarily affects individuals aged 50 to 70 years, with a reported incidence rate of 3.0 per million per year in Japan.

Humira is AbbVie's flagship product, the first approved anti-TumorTumor Necrosis Factor-alpha (TNF-α) inhibitors, which are also the best-selling anti-inflammatory drugs globally, generated nearly $20 billion in global sales in 2018. In Japan, the approved indications for Humira include: rheumatoid arthritis (including inhibition of structural damage progression), plaque psoriasis, psoriatic arthritis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, intestinal Behçet's disease, non-infectious uveitis, posterior uveitis, or panuveitis, induction and maintenance therapy for moderately to severely active Crohn's disease (limited to patients with an inadequate response to conventional therapy), moderately to severely active ulcerative colitis (limited to patients with an inadequate response to conventional therapy), and pyoderma gangrenosum. (Bioon.com)

Original Source: AbbVie and Eisai Announce anapproval for additional indication of HUMIRA®, a fully Human Anti-TNFα Monoclonal Antibody, for the treatment of pyoderma gangrenosum for the first time in the world