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]), a fully human anti-TNF-alpha monoclonal antibody, for rheumatoid arthritis.
Humira exerts its effects by neutralising TNF-alpha, a cytokine that plays a central role in inflammatory responses.
The MHLW cleared the condition for approval on the basis of the review of the safety and efficacy of Humira in 3,084 patients with rheumatoid arthritis who participated in the all-case surveillance.
Previously, in April 2008, Humira was approved for the treatment of rheumatoid arthritis with the following condition for approval: ‘Until data for a pre-determined number of cases have been accumulated following the approval of Humira, a use-results survey in all patients receiving the drug should be continued to promptly obtain safety and efficacy data for Humira and take appropriate measures to ensure proper use of the drug.’
Abbott Japan is the marketing authorisation holder of Humira in Japan and Eisai is responsible for its distribution. The two companies are working together to promote the drug.