Teva says its MS drug works after Biogen drug fails
Teva Pharmaceutical Industries Ltd. said on Wednesday that its multiple sclerosis drug Copaxone was shown in a clinical trial to be effective in patients who had stopped responding to Avonex, a competing drug made by Biogen Idec.
Israel-based Teva said the study of patients with relapsing-remitting MS found that Copaxone reduced their annual relapse rate by an additional 57 percent over Avonex, and that neurologic disability did not worsen in 86 percent of patients.
Officials at Biogen Idec, based in Cambridge, Massachusetts, could not be immediately reached for comment.
Both drugs are approved to treat relapsing-remitting MS, the most common form of the disease, which causes a progressive disability that can include blurred vision, weakness, poor muscle coordination and loss of memory and mental function as nerves lose their insulating sheath.
The study involved 85 patients who had been treated with Avonex for at least 18 months before relapsing or experiencing intolerable toxicity. They were then switched to Copaxone and followed for an additional 36 to 42 months.
The results were published in the June issue of the European Journal of Neurology.
Dr. Omar Khan, associate professor of neurology at Detroit's Wayne State University and senior author of the study, said the results suggest that observation of relapse rates, patient tolerability, and toxicity assessment are valuable for determining when therapy should be switched.
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COPAXONE(R) Reduced Relapses and Stabilized Disability as Measured by Expanded Disability Status Scale, When Avonex(R) Failed
Wednesday May 31, 8:00 am ET
Significantly improved clinical course was observed after switching from Avonex(R)
KANSAS CITY, Mo., May 31 /PRNewswire/ -- Relapsing-remitting multiple sclerosis (RRMS) patients failing Avonex® (interferon beta-1a) therapy as defined in the study, achieved significant reductions in relapse rates and in Expanded Disability Status Scale (EDSS) scores, a measure of disability, upon switching to COPAXONE® (glatiramer acetate injection). In a study published in the June issue of the European Journal of Neurology, COPAXONE® was shown to reduce annual relapse rate by an additional 57 percent over Avonex®, and that neurologic disability, as measured by the EDSS, did not worsen in 86 percent of patients.
"Our data demonstrated the benefits of COPAXONE® in reducing relapse rate in patients who were not effectively treated or could not tolerate other immune modulating therapies," reported Dr. Omar Khan, M.D., associate professor of neurology and director of experimental therapeutics/clinical research, Multiple Sclerosis Center, Wayne State University, and senior author of the study.
A series of 85 consecutive RRMS patients treated with Avonex® for at least 18 months who experienced suboptimal clinical efficacy (at least one relapse in the previous year, n=62) or persistent intolerable toxicity (elevated liver function tests, low white blood cell counts, or post-injection fever, weakness, or fatigue for more than 24 hours after every injection, n=23), were switched to COPAXONE® in this open-label study and followed prospectively for an additional 36 to 42 months (average 37.5 months). While on COPAXONE® therapy, patients were seen every six months for neurological examinations, including EDSS scores.
Annualized relapse rate for the entire patient group after switching to COPAXONE® (glatiramer acetate injection) was reduced by 57 percent from 1.23 on Avonex® to 0.53 (p=0.0001). In the subset of patients who switched to COPAXONE® because of insufficient efficacy on Avonex® (n=62), the reduction was even more significant (61 percent), from 1.32 to 0.52 (p=0.0001). Patients who switched to COPAXONE® because of persistent toxicity on Avonex® (n=23), experienced an additional 23 percent reduction which did not reach statistical significance.
In all patients, the average EDSS scores, as a measure of neurological disability, significantly improved during the more than three years of COPAXONE® therapy, decreasing from 3.50 to 3.08 (p=0.0001). Improved or stable EDSS scores occurred in 86 percent of patients.
"We recognize the limitations of our study, such as the open-label design and lack of prospective follow-up in patients while receiving IFN beta-1a," stated Dr. Khan. "However, our results corroborated another larger prospective open-label study by Howard Zwibel, M.D., Medical Director of Health South Doctors' Hospital Multiple Sclerosis Center, which demonstrated reductions in relapse rates in patients switched from Betaseron® to COPAXONE®, and suggested that clinical observations including relapse rates, patient tolerability, and toxicities assessed by serum laboratory parameters are valuable criteria for determining when a switch in therapy is warranted."
It's also interesting in the other study you posted on Bromley, that they are testing a double dose of copaxone and finding that it's more effective. Hasn't copaxone been approved for about 1 million years?! Why are they just getting around to this now? I also find it a bit confusing because there was at least one study that tested taking copaxone every OTHER day rather than every day which found that there was not a statistically significant difference in efficacy...so why is a higher dose helping? Would a double dose taken every other day be just as effective? Stay tuned...
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