The Ministry of Food and Drug Safety (MFDS) canceled the manufacturing and sales licenses for Kolon Life Science's degenerative arthritis gene therapy Invossa-K Inj on July 3. Kolon Life Science immediately expressed regret on the agency’s decision.
Following the final decision, the licenses of Invossa will be officially canceled on July 9.
The ministry said that Kolon Life Science received the licenses by stating that Solution 2 of the drug contains "cartilage-derived cells," while the solution was found to contain no cartilage cells.
As Invossa Solution 2 was identified to be kidney-derived cells as opposed to cartilage-derived cells, the company was selling the drug without its safe and efficacy having been confirmed at the risk of harming the public health.
In response to this decision, Kolon Life Science said, "In the hearing of the MFDS, we have explained that the ingredients of Invossa Solution 2 were different from the stated facts in the document due to a misunderstanding, but there was no intentional fabrication or concealment. We express deep regrets to the authorities’ decision to cancel the license.”
"We will file an administrative suit to seek a court judgment on whether the cancellation of the drug license is legitimate, and we hope to be able to provide the Invossa to patients who need it again," the company added.