Genzyme Fabrazyme/Transkaryotic Replagal to committee
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's Endocrinologic & Metabolic Drugs Advisory Committee will consider competing Fabry disease therapies at its September meeting; Genzyme's Fabrazyme (agalsidase beta) will be reviewed Sept. 26, followed by Transkaryotic Therapies' Replagal (agalsidase alfa) Sept. 27. Presumably, the first-approved drug would gain seven years orphan drug exclusivity and block the other's approval. The agents are approved with co-exclusive orphan status in Europe, but FDA has never awarded simultaneous orphan exclusivit
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FDA's Endocrinologic & Metabolic Drugs Advisory Committee will consider competing Fabry disease therapies at its September meeting; Genzyme's Fabrazyme (agalsidase beta) will be reviewed Sept. 26, followed by Transkaryotic Therapies' Replagal (agalsidase alfa) Sept. 27. Presumably, the first-approved drug would gain seven years orphan drug exclusivity and block the other's approval. The agents are approved with co-exclusive orphan status in Europe, but FDA has never awarded simultaneous orphan exclusivity |