U.S. FDA Allows Kolon to Resume Invossa-K Clinical Trial

The U.S. FDA has allowed Kolon TissueGene to resume the phase 3 clinical trial of Invossa-K. At the same time, the U.S. FDA requested data on how to improve production processes for the gene medicine and on the stability of clinical samples.

Previously, the U.S. FDA told the subsidiary of Kolon Life Science in May last year to temporarily suspend the clinical trial.

The first gene therapy developed by a South Korean company was approved by the Ministry of Food and Drug Safety of South Korea in 2017. In March last year, however, the approval was canceled and the clinical trial in the United States was suspended due to differences between actual medical components and those on documents.