(Source: Canada Newswire)
MONTREAL, April 16 /CNW Telbec/ - Teva Neuroscience Canada announced today that Health Canada has approved an expanded indication for COPAXONE(R) (glatiramer acetate injection) to include the treatment of patients who have experienced a single demyelinating event, accompanied by abnormal magnetic resonance imaging (MRI) scans and are considered to be at risk of developing Clinically Definite MS (CDMS), after alternative diagnoses are excluded. COPAXONE(R) administered to patients who have experienced a single demyelinating event has been shown to delay the onset of definite MS and reduce the number of active brain lesions and overall disease burden identified by MRI scans.
COPAXONE(R) is also indicated for the treatment of ambulatory patients with Relapsing Remitting Multiple Sclerosis (RRMS) in order to decrease the frequency of clinical exacerbations and reduce the number and volume of active brain lesions identified by MRI scans
Health Canada's approval follows recent decisions by the FDA and the European Medicines and Healthcare Products Regulatory Agency (MHRA) to expand the label for COPAXONE(R) to include the treatment of patients with clinically isolated syndrome (CIS) suggestive of MS.
Up to 85% of MS patients initially experience a single neurological event suggestive of MS, known as CIS, and it has been demonstrated that early treatment initiation delays conversion from CIS to clinically definite MS (CDMS). This expanded indication in Canada allows Canadian patients to begin treatment with COPAXONE(R) from the very early stages of the disease.
"The PreCISe trial exemplifies Teva's dedication and commitment to further improve our understanding of MS and to provide additional benefits to patients affected by demyelinating disorders", said Dr Jean Godin, General Manager of Teva Neuroscience Canada. "This expanded indication for COPAXONE(R), the leading MS disease modifying therapy both in Canada and globally, represents another significant step towards reaching our vision to be the North American leader in neurology through the quality of our people, the quality of our products, and our focus on the patient."
Health Canada granted approval after reviewing the results of the PreCISe study, which indicated time to development of a second exacerbation was significantly delayed in patients treated with COPAXONE(R) compared to placebo (Hazard Ratio (equal sign) 0.55; 95% Confidence Interval 0.40 to 0.77; p(equal sign)0.0005).
About the PreCISe Study
The multinational, multi-center, prospective, double-blind, randomized controlled, Phase III study was conducted globally in 80 centers. It included a total of 481 patients presenting with a single clinical episode and MRI scans suggestive of MS over a period of up to three years. Patients included were those who had a unifocal disease manifestation (i.e., clinical evidence of a single lesion).
