Research Evaluates Early and Sustained Clinical Effects Of COPAXONE(R) When Compared With Other Immunomodulating Therapies
Thursday April 3, 2003, 8:00 pm ET
Source: Teva Neuroscience, Inc.
As early as six months after starting therapy, COPAXONE® (glatiramer acetate injection) showed the ability to reduce relapses in relapsing-remitting multiple sclerosis (MS). In addition, benefits were sustained at 12 and 24 months, according to a poster presented this week at the American Academy of Neurology (AAN).
The study evaluated the time of onset of relapse rate reduction for people treated with COPAXONE® compared to those treated with other disease modifying therapies. This controlled, open-label study assessed how quickly COPAXONE® would begin showing clinical effects, such as relapse rate reduction.
"COPAXONE® demonstrated its ability to reduce relapses as early as six months in this study. This is comparable to the interferon data at six months. More significantly, the clinical benefit of COPAXONE® continued when reviewed after one year and two years on therapy," said Judith Haas, M.D., Jewish Hospital, Department of Neurology, Berlin, Germany.
The study is an ongoing prospective, controlled, open label trial that is looking at 255 people living with relapsing-remitting MS. At the start of the study, the annualized relapse rates for patients on all of the disease modifying agents were similar, ranging from 1.06 to 1.20. At six months, those taking COPAXONE® had a relapse rate reduction of 0.70 compared to baseline (p<0.001). Similarly the changes in relapse rate for all beta interferons at six months were statistically significant at the (p<0.02) level compared to 'prior to the study' relapse rate.
The COPAXONE® (glatiramer acetate injection) relapse rate reduction from baseline continued to improve with reductions of -0.73 at one year and -0.81 at two years, and that lowering was statistically significant than what was measured at the study outset (p<0.05).
COPAXONE® is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® is now approved in 42 countries worldwide, including the U.S., Canada, Australia, Israel and all the European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd., and Aventis Pharma. In North America, COPAXONE® is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies in the world. Close to 90 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 Pharmaceuticals USA is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE®.
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Source: Teva Neuroscience, Inc.
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