FDA approves Teva's longer-lasting Copaxone

The 40-ml dosage is administered by injection three times a week, instead of daily.

The US Food and Drug Administration (FDA) has approved the longer lasting version of Copaxone, Teva Pharmaceutical Industries Ltd.'s (NYSE: TEVA; TASE: TEVA) flagship drug for the treatment of multiple sclerosis. The larger 40-milliliter dosage is injected three times a week, instead of daily, as with the current treatment. Deliveries will begin immediately.

Teva will continue its regular versions of the drug, which was approved in 1996.

The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study of more than 1,400 patients, which showed that a 40 mg/ml dose of Copaxone administered subcutaneously three-times a week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis.

Erez Vigodman is set to take become Teva's president and CEO in February, after his nomination was approved by shareholders earlier this month.

Teva's share price rose 2.7% in after-hours trading on the New York Stock Exchange on Tuesday, following the announcement, to $45.28, after rising 0.8% during the session.

Published by Globes [online], Israel business news - www.globes-online.com - on January 29, 2014

© Copyright of Globes Publisher Itonut (1983) Ltd. 2014

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