Kolon Life Science might get its sales license of Invossa-K revoked, as the regulator found that the drug contained cell ingredients that were different from those at the time of approval in 2017.
Depending on the results of the Ministry of Food and Drug Safety’s investigation, the ministry could nullify approval for the arthritis treatment as an administrative punishment.
Kolon is making an all-out effort to keep the Invossa license intact because revocation of the license would threaten the company’s survival.
In the data submitted for approval, the company described Invossa as gene therapy for the treatment of moderate knee osteoarthritis. The company’s data said the drug consisted of “the first fluid (allogeneic chondrocytes)” and “the second fluid (chondrocytes transduced to express the therapeutic growth factor TGF-ß1).” Based on this report, the food and drug safety ministry granted the nod for Invossa as gene therapy for osteoarthritis.
However, the company announced in late March that its main ingredient cartilage cells were found to have been GP2-293 cells derived from the kidney, halting the local drug sales and the phase-3 trials in the U.S.
If the company’s data had indicated that the cells in the second fluid were kidney-derived cells instead of cartilage-derived ones, the regulator must have refused to approve. There is no precedent in the world that growth cells were used for gene therapy.
Some critics raised suspicion that Kolon might have intentionally tampered with data to report that the therapy used cartilage cells, even when it had known that the cells were derived from the kidney. If the company did so, the ministry is expected to revoke the sales license.
Nullification of the Invossa license could put Kolon in a life-or-death crisis. The drugmaker spent an astronomical amount of money to develop Invossa as a globally competitive innovative drug, conducting studies in the U.S. and making painstaking efforts to get approval in Europe and Japan.
On such a scenario, Kolon’s biotech business could lose trust at home and abroad. In the worst case, the company might suffer an irreversible loss and shut down the biotech business.
Kolon is in a panicky state to avoid the worst situation of getting the license revoked, claiming that “the transferred cells of Invossa have been 293 cells from the pre-clinical stage to date.”
The company is emphasizing that there is no problem in the safety and efficacy of the drug, continuously appealing to the food and drug safety ministry that license nullification will be unfair.
The ministry is waiting to see how strong an administrative punishment should be.
“We’re still investigating the Invossa case, and the result has not come yet. As we confirmed that the actual cells were different from the data submitted at the time of approval, however, it is possible that we could revoke the license,” a ministry official said.