Drug safety ministry revokes license of Invossa for mislabeling cell ingredient
- 5 years ago
식약처, 의약품 성분 바뀐 '인보사' 품목허가 취소...코오롱생명과학 형사고발
Just coming in.... South Korea's drug safety ministry has canceled its license for gene therapy drug Invossa... after its manufacturer was found to have mislabeled its active ingredient.
For more on this, we have our Yoon Jung-min on the line for us.
Jung-min, what's the latest on this?
Hi, Ji-yoon. As you mentioned, a matter of hours ago, the Ministry of Food and Drug Safety pulled Invossa's license.
Invossa was marketed as a gene therapy for the treatment for arthritis of the knee.
The ministry has also decided to push prosecutors to file charges against Invossa's manufacturer Kolon Life Science.
The ministry announced the result of on-site investigation into its developer Kolon TissueGene in the U.S.,... and found that the cell ingredient used in the treatment was different from the one specified in its application for official approval.
Originally, the cell therapy was reported as being from a cartilage cell, but it was found to have been a kidney-derived cell.
The ministry added Kolon Life Science filed false documents to cover up the scandal and failed to come up with scientific grounds.
The company suspended distribution and sales of the drug in April, some two years after the therapy won approval for commercialization in 2017.
Invossa has been selling in South Korea, Hong Kong and Macau, and was in a phase three clinical trials in the U.S.
And what will the authorities do to help those patients who have been using the drug?
How are they going to try to prevent similar incidents from happening again?
The ministry says it's going to monitor those who have already injected the gene therapy, including extensive medical checkups and long-term care.
It has been reported that more than 3-thousand people have used the therapy so far.
Meanwhile, 244 people in South Korea who used the gene therapy said they are going to file a lawsuit today against the companies involved worth more than two-million U.S. dollars.
Also, the drug safety ministry has promised to bolster its safety management system from the beginning of development to the distribution of drugs.
It said it's going to check and verify critical factors by itself from now on.
That's all I have for you at this hours, but I'll bring more updates on that. Ji-yoon.
Just coming in.... South Korea's drug safety ministry has canceled its license for gene therapy drug Invossa... after its manufacturer was found to have mislabeled its active ingredient.
For more on this, we have our Yoon Jung-min on the line for us.
Jung-min, what's the latest on this?
Hi, Ji-yoon. As you mentioned, a matter of hours ago, the Ministry of Food and Drug Safety pulled Invossa's license.
Invossa was marketed as a gene therapy for the treatment for arthritis of the knee.
The ministry has also decided to push prosecutors to file charges against Invossa's manufacturer Kolon Life Science.
The ministry announced the result of on-site investigation into its developer Kolon TissueGene in the U.S.,... and found that the cell ingredient used in the treatment was different from the one specified in its application for official approval.
Originally, the cell therapy was reported as being from a cartilage cell, but it was found to have been a kidney-derived cell.
The ministry added Kolon Life Science filed false documents to cover up the scandal and failed to come up with scientific grounds.
The company suspended distribution and sales of the drug in April, some two years after the therapy won approval for commercialization in 2017.
Invossa has been selling in South Korea, Hong Kong and Macau, and was in a phase three clinical trials in the U.S.
And what will the authorities do to help those patients who have been using the drug?
How are they going to try to prevent similar incidents from happening again?
The ministry says it's going to monitor those who have already injected the gene therapy, including extensive medical checkups and long-term care.
It has been reported that more than 3-thousand people have used the therapy so far.
Meanwhile, 244 people in South Korea who used the gene therapy said they are going to file a lawsuit today against the companies involved worth more than two-million U.S. dollars.
Also, the drug safety ministry has promised to bolster its safety management system from the beginning of development to the distribution of drugs.
It said it's going to check and verify critical factors by itself from now on.
That's all I have for you at this hours, but I'll bring more updates on that. Ji-yoon.