Sangamo Therapeutics, Inc. (SGMO) has recently provided updates on the U.S. and European regulatory movements for its gene therapy product candidate, isaralgagene civaparvovec or ST-920, manufactured to treat Fabry disease. The U.S. Food and Drug Administration (FDA) has expressed that data gathered from a single, suitable, and well-regulated study might commit the fundamental basis for the approval of a Biologics License Application (BLA) for isaralgagene civaparvovec. In addition, the European Medicines Agency (EMA) has awarded PRIME status to isaralgagene civaparvovec.
Nathalie Dubois Stringfellow, the Chief Development Officer at Sangamo, spoke on the matter: "The agreement on a regulatory course that could possibly present a new treatment alternative for Fabry disease patients on a fast-tracked, cost-efficient timeline."
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