Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has gained regulatory approval to use Copaxone for earlier stage multiple sclerosis patients.
Teva obtained EU Medicines and Healthcare products Regulatory Agency (MHRA) approval to expand the use of Copaxone for the treatment patients with clinical isolated syndrome (CIS) suggestive of multiple sclerosis. The approval applies to 24 EU member states that participate in the MHRA mutual recognition procedure.
The Australian Health Authority also approved the expanded use of Copaxone. The US Food and Drug Administration (FDA) is conducting a similar review.
The MHRA approved Copaxone for this use following a PreCISe study on patients with CIS. The study found that Copaxone significantly reduced the risk of developing clinically definite multiple sclerosis (CDMS) by 45% compared with patients who received a 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 eight out of ten patients who take the drug are still able to walk unassisted after a mean of 15 years of therapy and 22 years of disease duration.
Teva's share fell 1% on Nasdaq yesterday to $42.05. The share fell 1.3% at the opening on the TASE today to NIS 170.60, in line with the general market trend.
Published by Globes [online], Israel business news - www.globes-online.com - on February 5, 2009
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