FDA approves Abbott's Humira Pen for arthritis

By Lisa Kerner

Charlotte, N.C., June 26 - The Food and Drug Administration has approved Abbott's Humira Pen, used to administer Humira (adalimumab) for the treatment of moderate to severe rheumatoid arthritis and psoriatic arthritis.

The Humira Pen, available in the United States this August, will contain the standard dose (40 mg every other week) of the fully human monoclonal antibody as in the prefilled syringe currently in use, according to a company news release.

To administer Humira with the pen, patients place it against the skin, press a button, and wait for the medicine to inject.

Abbott said in its Touch study of 52 Humira prefilled syringe patients, nine out of 10 preferred the pen for its convenience and ease of use, while eight out of 10 found it to be less painful than standard injections.

"With the approval of the Humira Pen, Abbott furthers its goal of empowering patients to treat these potentially debilitating autoimmune diseases as conveniently as possible," divisional vice president, immunology development, Rebecca Hoffman said in the release.

Rheumatoid arthritis, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints, affects about 5 million people worldwide. In addition to joint pain and inflammation, psoriatic arthritis includes dry, scaly skin and patches of red, raised skin (plaques).

Abbott, located in Abbott Park, Ill., develops and markets pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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