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FDA panel rejects label expansion of AbbVie's Humira

World News | July 24, 2013


Selina McKee

FDA panel rejects label expansion of AbbVie's Humira

FDA advisors have reportedly turned down AbbVie's Humira for the treatment of a spinal inflammatory disease.

The drugmaker is seeking to expand the drug's existing indication for ankylosing spondylitis to include the treatment of non-radiographic axial spondyloarthritis, an inflammatory disease characterised by back pain.

 

But at yesterday's meeting of the Arthritis Advisory Committee, panel members voted 12-one against approving Humira (adalimumab) in this setting, according to Reuters.

 

Official documents posted on the agency's website ahead of the meeting had put a question mark over the design of trials submitted in approval application.

 

For one, long-term data were not provided that would enable a determination of the safety profile of Humira over time in the different axial spondyloarthritis subgroups, it noted.

 

Advisors have now reportedly asked for additional studies to be carried out to help determine whether it should be used to treat patients with the condition who have had an inadequate response to, or are intolerant to, a non-steroidal anti-inflammatory drug.

 

Interestingly, the European Commission gave Humira a green light for axial spondyloarthritis last year, making it the only approved medication available for the condition.

 

In the US, Humira (adalimumab) was approved for ankylosing spondylitis back in 2006, but it is also licensed to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s Disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis and ulcerative colitis.

 

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