Sangamo Therapeutics, Inc. (SGMO) announced U.S. and European regulatory updates for isaralgagene civaparvovec, or ST-920, the company's gene therapy product candidate for the treatment of Fabry disease. The FDA has agreed that data from a single, adequate, and well-controlled study may form the primary basis of approval of a BLA for isaralgagene civaparvovec. Also, the EMA has granted PRIME eligibility to isaralgagene civaparvovec.
Nathalie Dubois Stringfellow, Chief Development Officer of Sangamo, said: "The alignment on a regulatory pathway that could potentially deliver a new treatment option for Fabry disease patients on an expedited, cost-effective timeline."
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