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Abbott faces FDA delay for Humira as colitis treatment

US regulator wants more information on the biologic drug

Humira - AbbottAbbott Laboratories looks set to face a delay of several months in its attempt to get US approval for Humira as a treatment for ulcerative colitis.

The company confirmed yesterday it received a complete response letter from the FDA towards the end of 2011, saying that it needed additional information before approval of Humira (adalimumab) in colitis could be granted. 

Last month, Abbott got the go-ahead to market Humira as a colitis treatment in Europe, saying at the time that the drug was the first and only self-injectable biologic therapy to be registered for this indication.

The company has been tight lipped about the reasoning behind the FDA's decision to ask for more data, saying only that additional information has already been submitted to the agency and a verdict is expected by the end of the year.

Abbott filed for approval of Humira in the new indication based on trial results which showed the drug achieved a remission rate of 16.5 per cent among ulcerative colitis patients who had failed prior treatment with conventional drugs such as corticosteroids and immunosuppressant agents, compared to 9.3 per cent of those given placebo.

Humira is already widely approved for another inflammatory bowel condition called Crohn's disease, and is licensed in five other indications, including rheumatoid arthritis. It had been tipped to make rapid headway in the colitis market as it is suitable for self-administration at home, and also because there are relatively few approved drugs to treat the disease.

Biologic therapies used to treat ulcerative colitis include Merck & Co/Johnson & Johnson's Remicade (infliximab) and Simponi (golimumab), as well as Pfizer's Enbrel (etanercept).

Sales of Humira approached $8bn last year and analysts had predicted that approval in ulcerative colitis would help it reach $9bn in 2012, setting it on course to become the top-selling medicine in the world.

23rd May 2012


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