The Ministry of Food and Drug Safety has revoked the sales approval for Kolon Life Science’s Invossa-K after confirming that the company had manipulated the data submitted during the application process.
|Kang Seog-youn, director of the Food and Drug Safety Ministry’s Biopharmaceutical and Herbal Medicine Bureau Department, announces the revocation of Kolon Life Science’s Invossa-K, during a media briefing at the ministry headquarters in Cheongju, North Chungcheong Province, on Tuesday.|
The ministry said it would also file a complaint with the prosecutor against the company for submitting the false data to receive sales approval for the product.
With the ministry’s decision Invossa-K, which had held the title for the world’s first-in-class cell gene therapy to treat osteoarthritis of the knee, is at risk of disappearing from the market.
Invossa is comprised of human chondrocytes (HC, 75 percent) and transformed cells (TC, 25 percent). In 2004, the company thought TCs were derived from cartilage. In April this year, however, the company found that TCs were HEK 293 cells, derived from the kidneys. Kolon Life Science discovered the mislabeling after a voluntary STR testing, often used for paternity testing. STR testing demonstrates specific profiles of cells through genetic test analysis.
The 293 cells are noticeably different from healthy cells in the speed of proliferation, and the expressions as the former proliferate indefinitely just like cancer cells.
The company suspended the distribution and sales of the treatment voluntarily but immediately met with severe backlash from the government and patient groups.
The ministry’s decision came after its inspection of Kolon TissueGene last week. The investigation confirmed that Kolon Life Science knew about the number and location of the TGF-β1 genes inserted into the cells had been altered before authorization. Instead of reporting the facts to the ministry, the company hid them and did not submit relevant data.
The ministry also confirmed that Kolon Life Science’s treatment contained 293 cells two years earlier, on March 13, 2017, and posted such facts on May 3, 2019. As Kolon Life Science received the results of these tests in an email on July 17, 2017, the ministry judged that the company knew that its treatment contained the 293 cells.
According to relevant regulations, the company will not be able to reapply for sales approval for at least a year. The Korea Exchange has also suspended the trading of shares of both Kolon Life Science and Kolon TissueGene for the entire day on Tuesday.
The stock market operator said that the decision was to protect investors.
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