Kolon Group's "Invossa," a new drug for osteoarthritis cell genes that was embroiled in a controversy over ingredients, has been approved by the U.S. Food and Drug Administration (FDA) to resume phase III clinical trials.
The U.S. FDA has lifted a "clinical hold" on the U.S. clinical phase 3 of Invossa, which is being developed by its subsidiary Kolon TissueGene, to resume the three-phase test, said an official of Kolon TissueGene.
Kolon TissueGene is a subsidiary of Kolon Life Science and is in charge of development and approval in the U.S.
"All clinical retention issues have been resolved satisfactorily," the U.S. FDA said in an official letter to Kolon TissueGene saying, "FDA has lifted clinical retention and Kolon TissueGene can proceed with clinical trials of Invossa."
Invossa received approval from the Ministry of Food and Drug Safety as the country's first gene therapy drug in 2017, but controversy erupted in March last year when it was revealed that one of the main ingredients was kidney cells with possible tumors, not cartilage cells, contrary to Kolon's claim.
In response, the FDA suspended the clinical trial of Invossa in the U.S. in May last year, and the Ministry of Food and Drug Safety revoked the item's license in July and filed criminal charges against Kolon Life Science.
With the FDA decision, Kolon TissueGene will be able to resume clinical trials about 11 months after the U.S. FDA decided to hold off the trials of Invossa in May last year.
