Abbott / D2E7 (Adalimumab) BLA
ABBOTT PARK, Ill., April 9 /PRNewswire-FirstCall/ -- Abbott Laboratories (NYSE: ABT - news) today announced that it has simultaneously submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Agency for the Evaluation of Medicinal Products (EMEA) seeking approval to market D2E7 (adalimumab, ay-da-lim-yoo-mab) for rheumatoid arthritis (RA). D2E7 is the first fully human monoclonal antibody to be developed. D2E7 was designed to specifically block the activity of tumor necrosis factor alpha (TNF-Alpha), which plays a central role in the inflammation in autoimmune diseases such as RA. In patients with RA, there is an excess of TNF-Alpha that accumulates in the joints and contributes to the inflammation and joint destruction associated with the disease.
The submissions in the United States and Europe are based on data from 23 clinical trials involving more than 2,300 RA patients in North America, Europe and Australia, making D2E7 the most-studied anti-TNF agent at the time of submission for regulatory approvals. In these clinical trials, D2E7 was studied in adults with moderate-to-severe RA who had inadequate responses to one or more traditional disease-modifying anti-rheumatic drugs (DMARDs). Dosed every other week, D2E7 has been studied with and without methotrexate, and other commonly used traditional DMARDs.
``We have confidence in the promising data for D2E7, which reflect an evaluation in the largest number of patients in clinical trials included in regulatory submissions for an anti-TNF agent in RA,'' said Jeff Leiden, M.D., Ph.D., president and chief operating officer, Pharmaceutical Products Group, and chief scientific officer, Abbott Laboratories. ``It is our hope that D2E7 will provide an important and convenient treatment option for patients suffering from the debilitating effects of RA.''
Monoclonal antibodies mimic naturally occurring antibodies. In the case of RA, monoclonal antibodies can recognize and neutralize proteins that play a role in promoting the inflammatory process associated with RA. Fully human monoclonal antibodies have a protein structure that makes them essentially indistinguishable from antibodies present in the human body and represent the latest advance in the evolution of monoclonal antibodies for therapeutic use. D2E7 is the first fully human monoclonal antibody developed for the treatment of RA.
In clinical trials, D2E7 was administered by subcutaneous injection (a shot administered beneath the skin) every other week. At the time of submission, some patients had been taking D2E7 in clinical trials for more than three years.
In D2E7 clinical trials, disease activity was measured using the American College of Rheumatology (ACR) criteria. Some studies also included radiographic (X-ray) tests to further characterize disease activity. The studies also monitored the impact of the disease on the daily activities of the patients. The company anticipates presenting data from Phase III trials at upcoming medical meetings... |
