Abbott’s Humira gets another use approval from EU

Humira, Abbott Laboratories’ immunosuppressant drug, has been approved by the European Commission for use in ankylosing spondylitis (AS) – the third use approved for the drug.

AS is a type of arthritis affecting the spine which can eventually cause fusion and complete rigidity. It is more likely to affect men than women and often occurs in young men aged under 30. In some cases it can cause eye pain and hypersensitivity to light, as well as intestinal and skin problems.

A clinical phase III trial for Humira found that the drug was successful in reducing inflammation and pain. Additional data has shown that some patients achieve partial remission, greatly improving their quality of life.

Rebecca Hoffman, divisional vice-president for immunology development at Abbott, remarked: “Today’s approval of Humira as a treatment for severe, active ankylosing spondylitis marks another milestone for Abbott, and more importantly for patients, in providing new treatment options for this potentially debilitating autoimmune disease.”

“Tens of thousands of Europeans with rheumatoid arthritis and psoriatic arthritis have been prescribed Humira. Now thousands of Europeans with AS have the option of Humira as well,” she added.

Humira was discovered by Cambridge Antibody Technology (CAT), which was bought last month by AstraZeneca for over 700 million pounds. CAT licensed the drug to Abbott but recently sued over its cut of royalty payments of Humira’s sales. The rate currently stands at 2.688 per cent. During 2005, sales for Humira reached $1.4 billion (757 million pounds). CAT says Abbott expects 2006 sales to exceed $1.9 billion.

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