Humira adalimumab regulatory update

Last July, the U.K.'s NICE terminated a technology appraisal for Humira adalimumab to treat moderate to severe ulcerative colitis (UC) after Abbott Laboratories (NYSE:ABT, Abbott Park, Ill.) informed the agency it would not provide an evidence submission to support the review. Abbott said it would not be able to address the clinical and cost effectiveness in patients with acute exacerbation of UC who need hospitalization. Humira is approved in the U.S. and EU for the indication and to treat moderately to severely active Crohn's disease, adults with moderate to severe rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis and polyarticular juvenile idiopathic arthritis.

Eisai and Abbott, which spun out its pharmaceutical business into a separate public company called AbbVie, jointly developed Humira in Japan. Eisai and AbbVie co-promote it in Japan, Korea and Taiwan, while AbbVie has rights to the product elsewhere. AbbVie debuted on Jan. 2 (see BioCentury, Jan. 7). ...