Lantidra Chronology: 19 Years From IND Submission To Approval For The Cellular Therapy
Executive Summary
Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of CellTrans’ treatment for type 1 diabetes.
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Lantidra’s First-Cycle Complete Response Letter Centered On Inspection And Product Quality Issues
Although the CRL delayed the cell therapy’s approval by almost two years, additional CMC-related testing requested by the FDA ultimately came to be seen as a good thing by sponsor CellTrans because it provided assurance of product consistency.
‘Poor Quality’ Submission: CellTrans’ Lantidra BLA Marked By Missing And Incongruent Data
FDA's review of documents and source data files to assess product efficacy and subject safety was complicated by missing and inconsistent data, the clinical reviewer said, concluding there was insufficient data monitoring during clinical studies or in preparing the documents for regulatory submission.
BrainStorm’s NurOwn Gets Many, Many Thumbs Down From US FDA Panel
In overwhelmingly concluding that efficacy has not been demonstrated for the mesenchymal stromal cell therapy, panelists went beyond just the failed Phase III trial and cited BrainStorm’s ‘statistical magic’ and failure to adequately describe the mechanism of action, as well as safety and product quality concerns.