Abbott Laboratories Receives FDA Approval Earlier Than Anticipated For HUMIRA(TM) (adalimumab) for the Treatment of Rheumatoid Arthritis (RA).

Publication: PR Newswire

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- HUMIRA Offers Safety and Efficacy, Convenient Dosing and Unique, Easy-To-Administer, Pre-Filled Syringe for RA Patients -

Abbott Laboratories received U.S. Food and Drug Administration (FDA) approval to market HUMIRA(TM) (pronounced Hu-'mare-ah) (adalimumab) (pronounced a-da-'lim-yoo-mab), previously known as D2E7. HUMIRA is the first human monoclonal antibody approved for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs). HUMIRA was created using phage display technology, resulting in an antibody with human-derived heavy and light chains variable regions and human IgG1:K constant regions.

"We're pleased to receive the approval of HUMIRA earlier than anticipated," said Miles D. White, chairman and chief executive officer, Abbott Laboratories. "The approval of HUMIRA is not only a milestone for Abbott, more importantly it is an example of the positive impact pharmaceutical innovation can have for people living with chronic and debilitating conditions like RA."

HUMIRA will offer convenient every other week dosing by subcutaneous injection (shot beneath the skin). A specially designed prefilled syringe for RA patients whose hands may be affected by crippling joint destruction will be available in pharmacies next month. Abbott is confident it can supply sufficient quantities to meet patient demand and recently announced a...

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