The Ministry of Health, Labor and Welfare (MHLW) of Japan has cleared Abbott Japan and Eisai's Humira pre-filled syringe 40 mg/0.8 ml for subcutaneous injection (adalimumab [genetic recombination]) for crohn's disease and ankylosing spondylitis as additional indications, dosage and administration of the drug.
Humira, a fully human anti-TNF monoclonal antibody that exerts its effects by neutralising TNF, is a cytokine that plays a central role in inflammatory responses.
Humira is already indicated in Japan for rheumatoid arthritis (approved in April 2008), plaque psoriasis and psoriatic arthritis (approved in January 2010).
In two placebo-controlled, double-blind comparative studies conducted in Japan in patients with moderate or severe Crohn’s disease, Humira demonstrated efficacy in inducing and maintaining remission and tolerability equivalent to that observed in foreign studies.
Abbott Japan is the marketing and manufacturing authorisation holder of Humira in Japan. Eisai will be responsible for its distribution.