Late February: Kolon Life Science, Kolon TissueGene recognize mislabeled cell ingredients in Invossa-K
March 22: Kolon Life Science reports it to the Ministry of Food and Drug Safety
March 31: Ministry of Food and Drug Safety suspends the sale of Invossa
The Ministry of Food and Drug Safety and Kolon Life Science have come under fire for poor and slow responses amid a revelation that it took a month for the regulator to suspend Kolon’s possibly problematic gene therapy Invossa-K.
During the one month from the company’s recognition of the issue to the drug suspension, physicians kept prescribing the arthritis treatment. However, both the government and the drugmaker failed to identify which patients and how many of them received the injection.
According to Kolon Life Science, the company received a report from its partner firm, BioReliance, in late February that some of the cells in the working cell bank, being prepared for clinical trials in the U.S., might be 293 cells derived from the kidney.
Kolon requested a testing institution to check on the cells for sale in Korea and those for the trials in the U.S. and sent samples on March 14.
“In late February, we notified the ‘possibility’ that the cells might be 293 cells. We needed to confirm it through data verification. That's why we did not report the case to the food and drug safety ministry immediately,” Kolon Life Science said.
“As no severe case such as disease, disability, or death occurred, we were not obliged to report the case to the ministry in 15 days,” the company added, brushing off the suspicion on the possible violation of the Pharmaceutical Affairs Act.
The problem was that Invossa contained 293 cells, whereas all the working cell bank is supposed to be derived from one master cell line. In other words, the company must have known that Korean patients have received 293 cell-containing Invossa injections.
Critics question why the company revealed it belatedly.
They also question why the food and drug safety ministry did not take immediate action to notify the problem to patients, even after learning it from Kolon.
The ministry recognized the issue on March 22, when the interim result of the cell analysis on those for U.S. trials came out. However, nine days later, the ministry ordered the suspension of Invossa sale, on March 31.
The ministry’s countermeasures coming from March 22 did not include any response to patients treated with the suspended drug.
“On the day on March 22 when we received the interim result, we predicted that the final result would be identical and started to make response measures,” an official at the food and drug safety ministry told Korea Biomedical Review over the phone. “We could not suspend the drug immediately because we first had to identify what was the problem accurately,”
The company and the regulator’s poor responses left Invossa exposed and prescribed to patients for a month.
The ministry and the drugmaker do not even know the number of patients who received Invossa prescriptions in March. The number of patients disclosed by the two was recorded as of Feb. 28.
Just before the Invossa mishap, Kolon Life Science boasted about how quickly Invossa prescriptions were growing in Korea. “As of December, the number of patients who had Invossa procedures exceeded 2,600. Released in November 2017, Invossa is selling for more than 200 procedures per month, which is regarded as a successful touchdown on the market,” Kolon said in a press release on Feb. 21.
If the company’s press release is real, there should be over 200 prescriptions of Invossa in March. “We haven’t identified the number of Invossa prescriptions for March. We can get the number if we ask Kolon Life Science,” another ministry official said.
Kolon also said it was trying to learn the number of patients who received Invossa prescriptions in March.
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