AbbVie GK, the Japanese subsidiary of AbbVie, Eisai and its subsidiary EA Pharma have received the additional approval for a new dosing regimen of Humira Pre-filled Syringe 40mg / 0.8mL for Subcutaneous Injection (adalimumab [recombinant], Humira).
Humira is a fully human, anti-TNF, monoclonal antibody formulation to be used in patients suffering from moderate to severe Crohn’s disease, and become less responsive to treatment with 40mg every two weeks to double the dose to 80mg every two weeks.
The usual adult dose of Humira used to treat Crohn’s disease includes an initial dose of 160mg of adalimumab (recombinant) administered subcutaneously (SC) followed by 80mg SC two weeks after the initial dose, and then after four weeks of the initial dose.
Eventually, 40mg SC is given every two weeks thereafter.
However, during the course, some patients became less responsive to their treatment, necessitating therapy aimed at ‘long-term maintenance of remission’, the aim of treatment for Crohn’s disease.
A Japanese clinical study recently revealed the efficacy of an increased dose of 80mg every two weeks in patients who become less responsive to the traditional dose.
This resulted in an additional approval being granted for a change in dosing regimen for these patients.
AbbVie is the marketing and manufacturing authorisation holder for Humira in Japan, while the company, along with EA Pharma, is co-promoting Humira for the indications in the field of gastrointestinal diseases such as Crohn’s disease, intestinal Bechet’s disease and ulcerative colitis.
Abbvie and Eisai are co-promoting Humira for the indications in the fields other than gastrointestinal disease including plaque psoriasis, rheumatoid arthritis, ankylosing spondylitis, arthropathic psoriasis and juvenile idiopathic arthritis.