October 22, 2002
Source: Teva Neuroscience
PR Newswire (US)
People living with relapsing-remitting multiple sclerosis who delay COPAXONE(R) (glatiramer acetate for injection) treatment for as little as nine months can accumulate additional lesions in their brain, reported a study published in the October 2002 issue of Neurology. The delay of starting therapy resulted in six new enhancing lesions per patient during the first nine study months that could have been prevented, according to the study.
The study used magnetic resonance imaging (MRI) to evaluate the brain lesions for patients who were on COPAXONE(R) for the entire 18-month period compared to those who switched from placebo to active drug after nine months.
"Over the entire 18 months of the study there were 35 percent fewer enhancing lesions among the patients who started drug therapy early," said Jerry S. Wolinsky, M.D., director of the MS Research Group at the University of Texas Health Science Center. "Patients continuously treated with drug had 23 percent fewer relapses than those who started just nine months later." Wolinsky believes this study strongly shows that relapsing-remitting MS patients should consider beginning drug therapy soon after diagnosis. Patients always on COPAXONE(R) (glatiramer acetate for injection) showed the benefits gained in the first nine months were sustained through the entire 18 months, indicating a benefit from continuous drug therapy.
The two-phase trial began as a nine-month placebo-controlled, double-blind study that showed that COPAXONE(R) significantly reduced MRI-measured brain lesions and reduced the relapse rate. The second phase, which is reported in this issue of Neurology, switched placebo patients to COPAXONE(R), evaluating if those on COPAXONE(R) could sustain the benefit shown in the first nine months and whether there was a difference in those who began therapy later. The majority of patients (224 of 239) chose to enter the study continuation, where patients were evaluated clinically and through MRIs on a quarterly basis.
"Over the extension, there was a 54-percent reduction in the mean number of enhanced lesions for those converted from placebo to COPAXONE(R) and an additional 24.6 percent reduction for those always on COPAXONE(R)," said Giancarlo Comi, M.D., of the Scientific Institute and University Ospedale San Raffaele, Milan, Italy. "Over the entire study, the accumulated T2 disease burden was less for those always on COPAXONE(R)."
COPAXONE(R) is indicated for the reduction of 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 41 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. In North America COPAXONE(R) is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd. , headquartered in Israel, is among the top 35 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 branded human pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D focuses on 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 http:/ /www.copaxone.com/ for more information about COPAXONE(R) or multiple sclerosis.
COPAXONE(R) (glatiramer acetate for injection) is a registered trademark of Teva Pharmaceutical Industries Ltd. See additional important information at http:/ /www.copaxone.com/pi or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.
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Source: Teva Neuroscience
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