Abbott and Eisai Seek Japanese Approval for Crohn’s Disease Treatment

29 September 2009 (Last Updated September 29th, 2009 18:30)

Abbott Japan and Eisai have submitted an application for approval of Humira as a treatment for Crohn's disease in Japan. Humira is a fully human monoclonal anti-TNF antibody jointly developed by the two companies, which has already received approval for the treatment of rheumatoid arthrit

Abbott Japan and Eisai have submitted an application for approval of Humira as a treatment for Crohn's disease in Japan.

Humira is a fully human monoclonal anti-TNF antibody jointly developed by the two companies, which has already received approval for the treatment of rheumatoid arthritis and psoriasis vulgaris.

Abbott Japan previously obtained approval to market and distribute Humira in Japan, while Eisai has approval to distribute the drug.

The request for approval is based on two placebo-controlled, double-blind comparative studies of Humira, which showed excellent efficacy equivalent to that observed in foreign studies.