À̹ÌÁö È®´ë [Photo by Lee Chung-woo]
South Korea`s health authorities Wednesday finalized its revocation of Kolon Life Science¡¯s gene therapy drug Invossa for mislabeling and false reporting of an ingredient used.
The Ministry of Food and Drug Safety made the final decision after a public hearing process held on June 18. On May 28, the ministry announced it would cancel marketing approval of the osteoarthritis drug and bring a criminal complaint against Kolon Life Science¡¯s CEO Lee Woo-suk. The cancellation officially goes into effect next Tuesday.
À̹ÌÁö È®´ë [Photo by Kolon Life Science]
Invossa, which was approved in 2017, consists of Solution 1 that contains homologous chondrocytes and Solution 2 featuring TGF-¥â1 gene-insertion homologous chondrocytes to support the growth of cartilage cells. But the cells in the second solution were found to have come from cancer-causing kidney cells instead of from cartilage cells as stated in the document submitted for approval.
The ministry argued Kolon Life Science intentionally did not disclose the mix-up before filing for approval. Kolon Life Science said the drug¡¯s efficacy and safety profile was demonstrated in clinical trials even though it was mislabeled. The company said it is preparing to file a lawsuit to cancel the ministry¡¯s decision, while making efforts to resume a phase 3 clinical trial suspended in the U.S. When it will submit documents to the U.S. Food and Drug Administration for the trial resumption has yet to be decided.
By Kim Byung-ho and Minu Kim
[¨Ï Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]