Teva gets FDA approval for expanded Copaxone use

Patients may begin treatment with Copaxone from the very early stages of the disease.

Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) has obtained US Food and Drug Administration (FDA) approval for expanded use of Copaxone in treating multiple sclerosis (MS). Permission has now been given to use the drug in treating patients who have experienced initial symptoms of MS and have magnetic resonance imaging features consistent with the illness.

The FDA’s approval follows a similar decision by the EU Medicines and Healthcare products Regulatory Agency (MHRA) for extending use of Copaxone for the treatment patients with early clinical indications 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.

This latest approval has significant benefits for MS sufferers. Research shows that 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 approval allows patients to begin treatment with Copaxone from the very early stages of the disease.

Teva’s VP global branded products Moshe Manor said, “This milestone, along with the existing long-term safety and efficacy data, further position Copaxone as a cornerstone in MS treatment.”

Teva's sales of Copaxone reached a record $2.26 billion in 2008.

Teva's share closed at $43.21 on Nasdaq yesterday, giving a market cap of $33.92 billion. On early afternoon trading on the TASE Teva's share was down 1.5% at NIS 182.10.

Published by Globes [online], Israel business news - - on March 4, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018