Copaxone(R) 15-Year Study In Multiple Sclerosis Patients Demonstrates Robust Long-Term Efficacy And Safety

Main Category: Multiple Sclerosis
Article Date: 28 Feb 2010 - 0:00 PDT

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Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced the publication of data from the 15-year clinical study with Copaxone® (glatiramer acetate injection), which is the longest prospective and continuous evaluation ever conducted in relapsing-remitting multiple sclerosis (RRMS) patients. The data were published in the February issue of the journal Multiple Sclerosis.

The 15-year clinical study demonstrated that more than 80 percent of patients were still walking without assistance despite a mean MS disease duration of 22 years, and two-thirds of patients have not transitioned to secondary progressive MS. Patients who remained in the study over a mean of 15 years showed a reduction in annualized relapse rate (ARR) from baseline as well as minimal increase in Expanded Disability Status Scale (EDSS). On average, the ARR in the ongoing cohort declined from 1.12 ± 0.82 to 0.25 ± 0.34 at the 15-year analysis.

Additionally, the study reinforces the established long-term safety profile associated with Copaxone®. The most common adverse events associated with Copaxone® were local injection-site reactions and immediate post-injection reactions. No other immune-mediated disorders, infections or malignancies were reported.

"This study is important for the MS community as it further confirms the benefits of continuous long-term use of Copaxone® and its ability to effectively slow the natural progression of this disease," said Corey Ford, M.D., Ph.D., primary investigator in the study and Professor of Neurology, Director of the Multiple Sclerosis Specialty Clinic and Assistant Dean for Research at the University of New Mexico Health Sciences Center. "It is encouraging to see such long-term results that further support the well-established benefit-to-risk profile of this treatment relevant to a life-long disease."

"We are pleased to see that results from this study reinforce the long term efficacy and safety of Copaxone®," said Moshe Manor, Teva's Group Vice President, Global Branded Products. "The longest term study extension further demonstrates Teva's investment in Copaxone® and our ongoing commitment to improve the disease course of MS."

This study represents the only prospective, open-label follow-up study designed to evaluate continuous immunomodulatory therapy in RRMS patients. The study, currently in its 19th year, was extended to 20 years based on the positive results seen thus far and the interest of the MS community in the long term outcomes of treatments for this life-long disease.

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® (glatiramer acetate injection) patients starting in 1991. Patients' EDSS scores were evaluated every six months. Confirmed disability progression was defined as ≥1.0 EDSS point increase sustained for six 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.

Fifty-seven percent of patients experienced either stabilized or improved EDSS scores, while 65 percent has not yet transitioned to Secondary-Progressive Multiple Sclerosis (SPMS). While being treated with Copaxone®, the mITT patients' ARR declined from 1.18+/-0.82 to 0.43+/-0.58/year.

About COPAXONE®

Copaxone® is indicated for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of Copaxone® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.

Copaxone® (glatiramer acetate injection) 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. Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.

Source
Teva Pharmaceutical Industries Ltd.

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