Abbott receives CHMP recommendation for new Humira approval
26 June 2012 11:36 in Pharmaceutical Company Product News
Abbott has been granted a positive recommendation for the approval of Humira as a treatment for axial spondyloarthritis.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the drug as a treatment for adults with severe axial spondyloarthritis who have no X-ray evidence of structural damage.
Clinical data from the ongoing Ability-I trial have demonstrated encouraging safety and efficacy in the treatment of this debilitating condition, for which there are currently few available therapies.
Dr John Leonard, senior vice-president for pharmaceutical research and development at Abbott, said: "This positive opinion reinforces our ongoing promise to making Humira available to a unique patient population with significant unmet medical need."
Currently, Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Earlier this year, the drug was also approved by the European Commission for the treatment of ulcerative colitis.
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