First Approved Cancer Treatment for TGCT Included DILIsym Simulations in FDA Review
Summary
The information from DILIsym modeling serves to help guide go/no-go decisions on major drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that drug-induced liver injury will not be an insurmountable obstacle to FDA approval. Dr. Paul Watkins, the Director of the Institute for Drug Safety Sciences at University of North Carolina and chair of the DILI-sim Scientific Advisory Board, said: “With DILIsym, regulators and drug developers alike can better assess safety risks to patients and thereby speed delivery of important new treatments, like pexidartinib, to the patients who need them. We are glad to see our tools continue to show up in regulatory reviews.” Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organizations imply endorsement by the United States Government. NAFLDsym and IPFsym are designed for target or compound evaluation of therapeutic efficacy in nonalcoholic fatty liver disease (NAFLD or NASH) and idiopathic pulmonary fibrosis (IPF), respectively. In addition to performing consulting services using the modeling software, the expert scientific team engages clients from initial program design through data input and “results” interpretation.
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