Teva Pharmaceutical Industries Ltd. announced new data from the longest prospective study of treatment to relapsing-remitting multiple sclerosis (RRMS), which proves robust efficacy and safety of COPAXONE® (glatiramer acetate injection). Findings demonstrated that more than 80 percent of patients were able to walk unassisted following 15 years of treatment and average disease duration of 22 years. The majority of the 100 patients in the study experienced either stable or improved disability rates over the duration of the study, as measured by the Expanded Disability Status Scale (EDSS), as well as a 78 percent reduction in annualized relapse rate (ARR) from baseline. These data further confirm the benefits of long-term, daily use of COPAXONE® in treating the RRMS, while reinforcing the already established excellent safety profile of the therapy. 

Based on the positive results of these data, patients will continue to be followed to 20 years of treatment. 

“These data are of value to the MS community, as they reassure the ability of COPAXONE to effectively slow the natural progression of this disease using daily treatment,” said Corey Ford, M.D., Ph.D., University of New Mexico and primary investigator of the study. “Until we find a cure for multiple sclerosis, patients and physicians need a treatment that can safely provide a clinical benefit over the long-term,” he added. 

These data were presented today at the World Congress on Treatment and Research in Multiple Sclerosis, the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS and LACTRIMS, in Montreal, Canada. 

About the Study 

The study “Continuous Long-Term Immunomodulatory Therapy in Relapsing Multiple Sclerosis: Results from the 15-Year Analysis of the U.S. Prospective Open-label Study of Glatiramer Acetate,” a follow up to the pivotal, Phase III trial, followed 100 ongoing COPAXONE® patients through February, 2008. Patients’ EDSS scores were evaluated every 6 months. Confirmed disability progression was defined as ≥1.0 EDSS point increase sustained for 6 months. Patients were classified as “stable/improved” if EDSS score changes were less or equal to 0.5 points. Proportions of patients who reached confirmed thresholds of EDSS 4, 6, or 8 while on COPAXONE®, and Kaplan-Meier (KM) estimates of median times to these thresholds were obtained. 

The study looked at both patients who received COPAXONE® treatment ongoing for an average of 13.6±1.3 years, as well as patients in a modified intention-to-treat (mITT) cohort (n=232), who received at least one dose of COPAXONE®, with an average treatment duration of 8.6±5.2 years. 

The ARR for the ongoing patient cohort declined from 1.12+/-0.82 to 0.25±0.34/year, and 57 percent of patients experienced either stabilized or improved EDSS scores. While being treated with COPAXONE®, the mITT patients’ ARR declined from 1.18+/-0.82 to 0.43+/-0.58/year; 54 percent of patients experienced stable/improved EDSS with COPAXONE® treatment. 

The estimated time for one quartile of patients in the mITT group to reach an EDSS of 4 was, on average, 3.98 years, versus 6.8 years for those patients who remained on COPAXONE® throughout the study. In both cohorts, less than 25 percent of patients reached EDSS of 6 and 8. 

About COPAXONE® 

COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. 

COPAXONE® is now approved in 51 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. 

See additional important information at http://www.copaxone.com/pi/index.html . 

About Teva 

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe. 

Source: Medical News Today