ABBOTT PARK, Ill. — Abbott Laboratories received approval to market Humira in the European Union (News – Websites) as a treatment for adult rheumatoid arthritis.
In a prepared statement, the company on Wednesday said adalimumab, known generically as adalimumab, will be available at pharmacies in Germany and the United Kingdom within five days, followed by other EU countries as each country adopts pricing and reimbursement policies.
Abbott filed for EU marketing approval in April 2002. The company received marketing approval from the U.S. Food and Drug Administration (News – Websites) Dec. 31, 2002, and from nine other countries since then.
In May, encouraged by year-to-date U.S. sales of the drug, Abbott again boosted its projection for Humira’s global 2003 sales to more than $250 million. Abbott’s total company sales were $17.7 billion in 2002.
Company representatives weren’t immediately available to say if that projection has changed following the EU approval.
Self-administered, usually in an under-the-skin injection every other week, Humira resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha, or TNF-a, a protein that plays a central role in the inflammatory responses of autoimmune diseases such as rheumatoid arthritis. The treatment competes directly with Enbrel from Wyeth Inc. (WYE) and Amgen Inc. (NasdaqNM:AMGN – News; AMGN) and with Remecade from Johnson & Johnson. (JNJ).
Abbott will offer Humira in specially designed pre-filled syringes designed for use by patients whose hands have been affected by their RA disease.