Added European indications for Abbott's Humira and Novartis' Afinitor

30 July 2012

US health care major Abbott Laboratories (NYSE: ABT) today announced that the European Commission (EC) has approved Humira (adalimumab) for the treatment of adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage.

Humira is the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA). This approval marks the eighth indication for HUMIRA in the European Union since the product's first approval in 2003.

"This first approval of an anti-TNF for non-radiographic axial SpA is a significant step forward in the disease management of these patients," said Joachim Sieper, head of rheumatology, Campus Benjamin Franklin of the Charite University Hospital, Berlin, Germany, noting that "Humira has demonstrated a positive benefit-risk profile in non-radiographic axial SpA and access to this treatment option may help physicians treat even more patients suffering from this disease."

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