ABBOTT PARK, Ill., Oct. 9 /PRNewswire-FirstCall/ -- Abbott Laboratories announced today the initiation of a study to make its investigational medication, D2E7 (adalimumab), available to rheumatoid arthritis (RA) patients in need of additional treatment options in several countries around the world. In the United States, the program is called the Access to Therapy (ACT) in RA study and it will allow patients with moderately to severely active RA who have failed treatment with one or more traditional disease-modifying anti-rheumatic drugs (DMARDs) to receive D2E7. Similar programs are being initiated in Europe.
D2E7 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) following Abbott's simultaneous submissions earlier this year.
"In my experience with RA patients, it is critically important to have multiple treatment options," said Dr. Arthur Weaver, M.D., clinical professor of medicine, University of Nebraska Medical Center. "D2E7 has been extensively evaluated in clinical trials and the availability of D2E7 gives rheumatologists another option for patients who have had an inadequate response to available therapies or do not have access to certain medications."
In the United States, the ACT study is designed as an open-label, multi-center study for patients with moderately to severely active RA who have failed one or more traditional DMARDs. Patients will receive D2E7 via subcutaneous injection with or without other DMARDs and responses will be evaluated at defined intervals. Those who achieve at least a 20 percent improvement in RA signs and symptoms (as measured by a decrease in tender and/or swollen joint counts) will be able to remain in the study.
"The ACT study is part of our commitment to help rheumatologists and RA patients fight this debilitating disease," said Jeff Leiden, M.D., Ph.D., president and chief operating officer, Pharmaceutical Products Group, and chief scientific officer, Abbott Laboratories. "As we have done in other therapeutic areas, we remain committed to developing and making promising treatments available to patients in need."
Physicians and patients in the United States who are interested in this study can obtain more information by calling 1-800-553-1618 or visiting the Abbott Web site at www.abbottimmunology.com. Abbott is also working with regulatory agencies in countries around the world to initiate similar programs. Based on local regulatory requirements, study design and protocol may differ. Currently, D2E7 has been made available via patient named basis programs or study protocols to patients in Europe. |
