Results from the longest prospective MS drug trial were released April 17 at the American Academy of Neurology's annual meeting. The study showed that the majority of patients treated with Copaxone(r) remained either unchanged or improved in their neurologic status during an eight-year period.
Fleishman-Hillard, Kansas City
DENVER, Colo. (Apr. 18, 2002) -- The majority of patients treated with COPAXONE(r) (glatiramer acetate for injection) remained either unchanged or improved in their neurologic status during an eight-year period in the longest prospective multiple sclerosis drug trial ever. These results were released today at the American Academy of Neurology annual conference in Denver, Colo.
"People in this study have had relapsing-remitting multiple sclerosis for an average of 15 years. Based on studies on the natural course of MS, half of those would be expected to use walking aids, such as a cane or a wheelchair, if left untreated. This study found that patients who received drug therapy had a mean EDSS of 3.17, which means most of them are still walking without assistance," said Kenneth P. Johnson, M.D., professor of neurology, director of the Maryland Center for MS at the University of Maryland, Baltimore.
This trial was originated in 1991, and 251 patients with relapsing-remitting MS were randomized into a double-blind, placebo-controlled trial of COPAXONE(r). The placebo-controlled phase lasted for approximately 30 months. Patients were then invited to continue in the open-label phase of the trial in which all patients received COPAXONE(r). Of the 251 patients, 208 continued in the open-label phase. At year eight, 68 percent or 142 patients remained in the study. This study presented the results eight years into the 12-year trial.
"One of the key questions was how the group that started on COPAXONE(r) (glatiramer acetate for injection) compared with the patients who spent 30 months on placebo. We discovered there was a consequence for delaying therapy," said Dr. Johnson.
Patients who received placebo at the beginning of the study were more likely to have worsened by more than one step on the EDSS (Expanded Disability Status Scale) (p=0.0263). The EDSS measures the levels of disability of a person with MS.
In addition, the relapse rate across the entire eight years was significantly better for patients always on COPAXONE(r) versus those who began on placebo (p=0.0459). The COPAXONE(r) group began the trial with a yearly relapse rate of 1.49 and that rate fell to 0.16 by year eight. For the group that began on placebo, the entry relapse rate was 1.45, falling to 0.23 by year eight.
COPAXONE(r) is indicated for the reduction in the frequency of relapses in relapsing-remitting MS. The most common side effects of COPAXONE(r) are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE(r) is now approved in 40 countries worldwide, including the U.S., Canada, Australia, Israel and all the European countries. In Europe, COPAXONE(r) is marketed by Teva Pharmaceutical Industries Ltd. and Aventis Pharma. In North America COPAXONE(r) is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 40 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. More than 80 percent of Teva's sales are in North America and Europe. The company develops, manufactures, and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as focusing on innovative R&D, developing novel drugs for diseases of the central nervous system.
Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd. Call 1-800-887-8100 or log onto www.copaxone.com for more information about COPAXONE(r) or multiple sclerosis.
COPAXONE(r) is a registered trademark of Teva Pharmaceutical Industries Ltd.
See additional important information at http://www.copaxone.com/pi.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.
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