The European Medical Association (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Abbott Laboratories’ Humira (adalimumab) drug in adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage.
EMA’s ruling was based on clinical data from Ability-I, an ongoing multi-country phase-three study.
AxSpA, which includes ankylosing spondylitis (AS) and nr-axSpA, can be a debilitating condition that causes chronic back pain and stiffness and can also be accompanied by the presence of arthritis, inflammation in the eye/gastrointestinal tract.
Humira will be indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, but with objective signs of inflammation by elevated C-reactive protein (CRP)/MRI who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs.
John Leonard, senior vice-president of pharmaceuticals research and development at Abbott, said:
For people with non-radiographic axial spondyloarthritis, there have been limited treatment options that offer relief for this painful and chronic disease. This positive opinion reinforces our ongoing promise to making Humira available to a unique patient population with significant unmet medical need.