Sangamo’s Fabry Gene Therapy Can Rely On 25-Person Registration Trial After US FDA Meeting

Sangamo Therapeutics, Inc. believes it has a plan for getting Fabry disease gene therapy isaralgagene civaparvovec to market after positive talks with regulators on both sides of the Atlantic.

The genomic medicine company has held a Type D meeting with the US Food and Drug Administration and the agency has agreed that data from "a single, adequate and well-controlled study may form the primary basis" of a biologics license application filing for isaralgagene civaparvovec, which is codenamed ST-920