STAT+: FDA suspends early study of Vertex stem-cell therapy for type 1 diabetes
Vertex Pharmaceuticals said Monday that the Food and Drug Administration had suspended an early-stage clinical trial of its stem-cell therapy for type 1 diabetes, citing “insufficient information” to support an increase in dosing.
The FDA’s decision to place a clinical hold on the diabetes therapy, called VX-880, was a “surprise,” Vertex Chief Operating Officer Stuart Arbuckle told STAT. The company and the study’s independent monitors recently reviewed data from the VX-880 study, concluding that there were no safety or efficacy issues to preclude advancing from a half dose to a full dose of the therapy.
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