Teva's COPAXONE Approved By the FDA for Patients With a First Clinical Event Suggestive of Multiple Sclerosis
Tue, 03/03/2009 - 5:20am
Teva Pharmaceutical Industries Ltd. has announced that the FDA has approved an expanded indication for COPAXONE(R) (glatiramer acetate injection) to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis (MS). The FDA's approval follows a similar decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) in February 2009 under which 24 EU member states have mutually recognized an expanded 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 the U.S. and Europe allows patients to begin treatment with COPAXONE(R) from the very early stages of the disease. "COPAXONE(R), the world's leading MS disease modifying therapy, has demonstrated the ability to provide treatment benefits very early on, when patients present with a first clinical episode and have MRI features consistent with MS," said Moshe Manor, Teva's Vice President, Global Branded Products, "This milestone, along with the existing long-term safety and efficacy data, further position COPAXONE(R) as a cornerstone in MS treatment." The FDA 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 0.55; 95% Confidence Interval 0.40 to 0.77; p0.0005). The cumulative probability of developing the second attack during the three year study period was significantly lower in the COPAXONE(R) group versus the placebo group (24.7% vs. 42.9. COPAXONE(R) is the only RRMS treatment with prospective long-term data demonstrating 8 out of 10 patients adhering to therapy are still able to walk unassisted after 15 years of therapy and 22 years of disease duration. An approval for an expanded label for COPAXONE(R) was also granted by the Australian Health Authority (Therapeutic Goods Administration, TGA) in December 2008.