FDA Pumps the Brakes on Fulcrum Sickle Cell Drug Trial

The US Food and Drug Administration (FDA) has put a damper on Fulcrum Therapeutics’ ambitions by placing a full hold on a clinical trial for the company’s new therapeutic, FTX-6058. The company says the FDA made the decision based on preclinical data, although the specific reason for the hold has yet to be reported.

According to Katherine Lewin, “Recent results had set the stage for fast track designation, a fairly routine FDA move that helped Fulcrum lay out a timeline for testing a higher dose of the drug — which “leads to potent downregulation of key fetal globin repressors, including BCL11A, thereby causing an increase in fetal hemoglobin (HbF).””

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(Source: Endpoints News, February 24^th, 2023)