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Isis Pharmaceuticals Inc's ISIS-TTR Secures Fast Track Designation

Thursday, 13 Dec 2012 08:00am EST 

Isis Pharmaceuticals Inc announced that the United States Food and Drug administration has granted ISIS-TTR fast track designation for the treatment of familial amyloid polyneuropathy (FAP). ISIS-TTR is an antisense drug in development with GlaxoSmithKline (GSK) for the treatment of transthyretin (TTR) amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Isis and GSK recently amended the clinical development plan and financial terms relating to ISIS-TTR to support a registration-directed Phase 2/3 clinical study on ISIS-TTR, which is expected to start this month. 

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