Teva Pharmaceutical Industries Ltd. posted new results from the PreCISe study, which demonstrated that early treatment with Copaxone (glatiramer acetate injection) significantly reduced the risk of developing clinically definite multiple sclerosis (CDMS) by 45 per cent compared to placebo.
Based on the PreCISE results, an application for marketing authorization in Europe to the Medicines and Healthcare products Regulatory Agency (MHRA) for the extension of its indication to include the treatment of patients with a first clinical event suggestive of MS, was submitted and is currently under review. A similar application requesting an expanded label for Copaxone will also be submitted shortly with the US Food and Drug Administration (FDA).
"Clinically isolated syndrome, or CIS, is a first neurologic episode, usually caused by inflammation or demyelination, which is indicative of possible development of multiple sclerosis," said Giancarlo Comi, M.D., University Vita-Salute San Raffaele, Scientific Institute San Raffaele, Milan, Italy, and principal investigator. "The PreCISe study results clearly demonstrate that early treatment with Copaxone, as early as CIS, reduces the risk of developing MS" he added.
Copaxone, currently indicated for RRMS, is a unique disease modifying treatment with a dual mode of action that has over 10 years of prospective clinical trial data demonstrating long-term clinical treatment benefits and good safety profile. The PreCISe results now extend Copaxone effect to CIS patients, demonstrating a reduced risk of developing Clinically Definite MS (CDMS). Furthermore, the safety profile of Copaxone in the PreCISe study was consistent with the well-established safety profile of the product based on many years of post-marketing surveillance and over 100,000 patients treated globally with Copaxone.
Moshe Manor, group vice president, global innovative resources, Teva Pharmaceutical Industries, Ltd., said, "These impressive results clearly demonstrate the potency of Copaxone in treating early phases of multiple sclerosis. Along with its lasting efficacy, confirmed over 10 years, it positions Copaxone as the preferred treatment option for multiple sclerosis patients".
The multi-national, multi-centre, prospective, double-blind, randomized, phase III study was conducted in approximately 100 centres located in the US, Europe, Argentina, Israel, Nordic countries, Australia and New Zealand. It included a total of 481 patients presenting with a single clinical episode and MRI suggestive of MS. Patients included were those who had a unifocal disease manifestation. Patients received either Copaxone 20mg/day or placebo as a subcutaneous injection and continued treatment for up to 36 months, unless a second attack was experienced and they were diagnosed with CDMS. Patients who converted to CDMS continued the trial on active treatment for an additional two years. The primary efficacy outcome was time to CDMS, based on a second clinical attack.
Copaxone (glatiramer acetate injection) was also demonstrated to be very well tolerated in the PreCISe study, with only 16 per cent overall dropouts during the up to three-year study period, similar to that observed in RRMS patients treated with Copaxone. All patients in the study participated in a follow-up study with Copaxone to prospectively assess the impact of early versus delayed treatment with Copaxone on the long-term course of the disease for a total observation time of up to five years.
A pre-planned interim analysis was performed on data accumulated from approximately 80 per cent of the three-year placebo-controlled study exposure. Results of the interim analysis, announced in December 2007, demonstrated the proportion of patients developing CDMS was reduced from 43 per cent in the placebo group to only 25 per cent in the Copaxone group. The PreCISe study also demonstrated that the 25th percentile of number of days to conversion to CDMS has more than doubled by Copaxone from 336 days to 722 days compared with placebo.
At the time of this analysis, the data monitoring committee (DMC) stopped the placebo arm of the study, as Copaxone successfully met the efficacy endpoint of the study.
Current data suggest Copaxone is a selective MHC (Major Histocompatability Complex) class II modulator. Copaxone is indicated for the reduction of the frequency of relapses in RRMS. It is very well tolerated and the most common side effects of Copaxonev are redness, pain, swelling, itching, or 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, all European countries, Canada, Mexico, Australia, and Israel. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, it is marketed by Teva Neuroscience, Inc.