The FDA is extending its regulatory review of Tysabri by up to 90 days.
The multiple sclerosis (MS) treatment market received an announcement today that Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) will welcome with a smile. Biogen Idec (Nasdaq: BIIB) and Elan Corp. (NYSE; Dublin: ELN; LSE: ELA) announced today that the US Food and Drug Administration (FDA) has notified the companies that it is extending its regulatory review of Tysabri by up to 90 days. This means that the FDA will announce its decision on the MS treatment, a rival of Teva’s Copaxone, no later than June 28.
When the FDA granted Tysabri marketing approval in December 2004, it became Copaxone’s greatest rival. In February 2005, several deaths were reported from use of the drug when it was combined with others. Tysabri was removed from the shelves immediately following the first death linked to the drug became known. Since then, the two companies and the FDA have been conducting a series of tests to find a link between the use of Tysabri in combination with other drugs and progressive multifocal leukoencephalopathy (PML), a rare central nervous system disease that can be fatal. Two weeks ago, the FDA held a panel on the subject to consider returning Tysabri to the market.
Tysabri may again be marketed, but with a warning about PML.
Published by Globes [online], Israel business news - www.globes.co.il - on March 22, 2006
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