Kolon Life Science will conduct the first test on patients who received Invossa-K from September, the Ministry of Food and Drug Safety said Thursday.
“Currently, our primary focus is on patient safety management,” Ministry of Food and Drug Safety Minister Lee Eui-kyung said. “If an Invossa-administered patient gets cancer, we plan to analyze the health insurance claim data to see if the treatment caused cancer.”
The ministry’s announcement comes after Kolon Life Science said in May that it would conduct a long-term follow-up study for 15 years on more than 3,700 patients who were treated with Invossa. The ministry will proceed with patient registration at the hospital and is discussing with Kolon Life Science in designating 20 hospitals that will be responsible for the follow-up for the next 15 years.
Kolon expected that the follow-up would cost more than 80 billion won ($66.9 million). In a public disclosure on May 15, the company said it set aside 62.1 billion won for the follow-up study.
The long-term follow-up will include a general blood test, serologic test, vital signs, TGF-b1 enzyme-linked immunosorbent assay (ELISA), TGF-b1 polymerase chain reaction (PCR), replication-competent retroviruses (RCR) test, X-ray, and genetic test.
Regarding foreign patients that received Invossa, the ministry and Kolon Life Science are considering methods where the patients themselves have to register with the system or receive a separate examination in their country and receive compensation from Kolon Life Science.
“Along with the Korea Institute of Drug Safety & Risk Management, the ministry will thoroughly supervise side effect management and reimbursement to ensure that patient safety is not neglected,” Lee said.
A hospital that administered Invossa to a patient should register the patient’s information with the “Invossa-K Injection Long-term Follow-up Patient Registration System” of the Korea Institute of Drug Safety and Risk Management. Patients can be informed about the registration process by visiting the hospital that prescribed Invossa or making a phone call. They can also contact Kolon Life Science’s call center at 02-3688-4020.
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