Teva Pharmaceutical Industries Ltd. announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved an expanded label for Copaxone (glatiramer acetate injection) to include the treatment of patients with clinical isolated syndrome (CIS) suggestive of multiple sclerosis (MS). This approval includes 24 EU member countries that take part in the MHRA "mutual recognition procedure". A similar application for the expanded Copaxone label is currently under review by the US Food and Drug Administration (FDA).
The PreCISe study, conducted in patients with CIS demonstrated that Copaxone significantly reduced the risk of developing clinically definite MS (CDMS) by 45 per cent versus placebo and prolonged the quartile time to conversion to CDMS to 722 days, versus 336 days in those patients receiving placebo.
Copaxone now has evidence-based data for early treatment and, in addition, is the only relapsing-remitting MS (RRMS) treatment with prospective long-term data demonstrating that 8 out of 10 patients adhering to Copaxone therapy are still able to walk unassisted after a mean of 15 years of therapy and 22 years of disease duration.
"Copaxone provides clear benefits from early phase of the disease to patients presenting with a first clinical event suggestive of MS", said Moshe Manor, Teva's Group vice president, global innovative resources, "This significant effect that adds on to the robust efficacy and safety data demonstrated over the last 15 years position Copaxone as a cornerstone in MS therapy".
Approval of an expanded label for Copaxone to include the treatment of CIS patients was also provided by the Australian Health Authority (Therapeutic Goods Administration, TGA).
The multinational, multi-centre, prospective, double-blind, randomized, phase III PreCISe study was conducted globally at 80 centres. It included a total of 481 patients presenting with a single clinical episode and magnetic resonance imaging (MRI) scans suggestive of MS. Patients included were those who had a unifocal disease manifestation (i.e., clinical evidence of a single lesion). Patients received either Copaxone 20mg/day or placebo as a subcutaneous injection and continued treatment for up to three years, 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 shown to be very well tolerated in the PreCISe study, with 84 per cent of patients completing the three-year study period; a rate 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.
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.. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.