The world's first treatment for gangrene sepsis (PG)! AbbVie's $20 billion annual Humira Japan is approved as the 12th adaptive disease!

November 29, 2020 // -- AbbVie and Eisai recently jointly announced that Humira (common name: adalimumab, Adamo single resistance) has been approved in Japan for a new adaptation to treat gangrenosum (pyoderma gangrenosum, PG).
this approval, making Humira the world's first drug to treat PG.
so far, Humira has approved as many as 12 adaptations in Japan.
in 2019, Humira was granted ODD status to treat PG orphans.
approval is based on data from a Phase 3 clinical trial in Japan conducted in Patients in Japan.
the study was conducted in patients diagnosed with PG, active ulcers, where local treatment was ineffective or judged unsuitable for topical treatment, to assess humira's efficacy and safety.
results showed that the study reached its main endpoint: in the 26th week of treatment, 54.5% of patients with anthrax sepsis ulcer area (PGAR) decreased by 100% (target PG ulcer healing).
study, the most common adverse drug reaction among patients treated with Humira was skin bacterial infection.
Gangrene sepsis (Photo: learnskin.com) PG is an inflammatory skin disease that develops rapidly after onset and is divided into five types: ulcer type, large herpe type, pustules type, proliferation type and type that occurs around pores.
ulcerative PG is the most common type, manifested as lower limb pain, pustules, papules and nodding, especially in the lower extremities, and actively dilates to form bulging ulcer lesions with edge immersion.
with severe pain, seriously affecting the quality of life of patients.
the pathogenic mechanism of PG is not fully clear, about 20-30% of PG cases are reported to be caused by minor injuries or external stimuli.
PG mainly affects people in their 50s and 70s, with a reported incidence rate of 3.0/million/year in Japan.
Humira is AbbVie's flagship product, the world's first approved anti-tumor necrotic α (TNF-α) drug and the world's best-selling anti-inflammatory drug, with global sales of nearly $20 billion in 2018.
In Japan, Humira has been approved for adaptive disorders including rheumatoid arthritis (including inhibition of progression of structural injuries), plaque-type psoriasis, arthritis psoriasis, pustules-type psoriasis, strong scolitis, polyarthritis, intestinal white congestion, non-intestinal white congestion Induced and maintenance treatment of infectious staphylococcitis, post-vineitis or whole vineitis, moderate to severe active Crohn's disease (for patients who do not respond well to conventional treatment only), moderate to severe ulcerative colitis (only for patients who do not respond well to conventional treatment), and gangrene sepsis.
() Original origin: AbbVie and Eisai Announce an approval for additional development of HUMIRA®, a fully Human Anti-TNF alpha monoclonal Antibody, for the treatment of pyoderma gangrenosum for first time in the world