Abbott Laboratories has received U.S. Food and Drug Administration (FDA) approval to market Humira (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 manufacturing expansion to meet future demand for Humira, as well as other biologics in its pipeline. The FDA's approval of Humira comes only nine months after simultaneous regulatory submissions in the United States and Europe.
Humira resembles antibodies normally found in the body. Humira works by specifically blocking tumor necrosis factor alpha (TNF-a), a protein that plays a central role in the inflammatory responses of autoimmune diseases such as RA.
Humira was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team would discover human antibody therapeutics. Humira was isolated and optimized by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to Humira, including responsibility for clinical development, manufacturing, sales and marketing. Abbott will book all revenues for Humira, and CAT will receive a royalty fee based on Humira sales.
The European Agency for the Evaluation of Medicinal Products (EMEA) accepted Abbott's submission for Humira for the treatment of RA in April 2002, and approval is anticipated in mid-2003.