The Ministry of Food and Drug Safety said there was no significant concern for patients who received Invossa-K injections because kidney-derived cells in the second fluid of the drug died 44 days after a cell death test.
The ministry said it conducted a cell death test from April 11 to May 26 and found that the cells did not exist 44 days after the test.
“In our test, we confirmed that all of the cells died, as expected. Considering the test results, radiations on the second fluid and the absence of serious adverse reactions in clinical trials, the safety of Invossa is not significantly worrisome,” said Kang Seog-youn, director general at the Biopharmaceuticals and Herbal Medicine Bureau of the food and drug safety ministry.
Kang said Invossa was believed to be effective in improving pains and functions of knees, as confirmed in clinical trials. However, as the company mislabeled kidney-derived cells as cartilage-derived cells, the ministry could additionally review the drug, he added.
“There is no such thing to be proved scientifically 100 percent. That is why we are doing a long-term follow-up study on patients treated with Invossa,” Kang said.
In the long-term follow-up, Kolon Life Science will have all patients injected with Invossa visit a hospital or clinic for a medical checkup interview, and investigate whether adverse reactions occur through genetic tests in blood and joints.
The government will also link hospitals with patients, registered with the “pharmacoepidemiological web-based investigation system” of the Korea Institute of Drug Safety and Risk Management, to analyze their medical history and adverse events.
Officials at the food and drug safety ministry are visiting and hospitals and clinics to help patients register with the system and making phone calls at 438 hospitals to encourage patient registration. As of Sunday, 245 medical institutions have completed the registration of 1,040 patients.
In the wake of the Invossa suspension, the ministry would enhance monitoring in all stages of drug development from R&D to approval to manufacturing and consumer use. The ministry would also reinforce its capability for reviewing advanced biotech products, including gene therapies.
A drugmaker will have to submit a new test result on a new medicine to the ministry if the drug needs verification again, Kang added. If the matter is significant enough, the ministry will conduct a test itself.
If the ministry suspects a foreign cell in a cell treatment, it will require the cell treatment developer to submit the results of genetic system testing of cells used for R&D and manufacturing.
The government will also apply stricter standards for advanced biopharmaceuticals, conduct genetic system testing, and mandatorily conserve the results, Kang said.
In the consumer use stage, the government will require long-term follow-ups, including the list of sales and distributions of advanced biopharmaceuticals and registration of adverse events.