ABBOTT PARK, Ill., Jan. 6 /PRNewswire-FirstCall/ -- Abbott Laboratories today announced it will begin supplying its newly approved biologic, HUMIRA(TM) (pronounced Hu-'mare-ah) (adalimumab) (pronounced a-da-'lim-yoo-mab), to pharmacies throughout the United States this week, making it available to people with rheumatoid arthritis (RA) by mid-January. 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 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. The FDA approved HUMIRA on December 31, 2002, only nine months after simultaneous regulatory submissions in the United States and Europe.
"We are committed to making HUMIRA available to people living with RA as quickly as possible and we're pleased to have begun supplying the product to pharmacies within a week of FDA approval," said Jeff Leiden, M.D., Ph.D., president and chief operating officer, Pharmaceutical Products Group, Abbott Laboratories. "We are also confident in our ability to meet current and future demand for the drug."
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.
Important Safety Information
Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections. Other invasive opportunistic fungal infections have also been observed in patients treated with TNF-blocking agents, including HUMIRA.
TNF-blocking agents, including HUMIRA, have been associated in rare cases with exacerbation of demyelinating disease. The most frequent adverse events seen in the placebo-controlled clinical trials (HUMIRA vs. placebo) were upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy. |
