Abbott's Humira gets European recommendation for treatment of arthritis of the spine

By Elaine Rigoli

Tampa, Fla., April 28 - Abbott announced Friday that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, granted a positive opinion recommending approval of Humira (adalimumab) for the treatment of severe active ankylosing spondylitis, or arthritis of the spine.

The European Commission is expected to issue a decision granting the marketing authorization for Humira as a treatment of ankylosing spondylitis in the European Union within about 60 days.

The positive opinion is based on results from a phase 3 trial evaluating long-term efficacy and safety, according to a news release.

In October 2005, Abbott submitted a supplemental Biologics License Application to the Food and Drug Administration seeking approval to market Humira as a treatment for ankylosing spondylitis.

The positive opinion is encouraging news for European ankylosing spondylitis patients because it signals that a new treatment option will soon be available to address the symptoms of the disease, officials said.

Abbott is an Abbott Park, Ill.-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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