식약처, 의약품 성분 허위 '인보사' 허가 취소...코오롱생명과학 형사고발키로
The Ministry of Food and Drug Safety has taken away the license for a drug called Invossa used to treat the most common form of arthritis.
Now the manufacturer faces lawsuits and criminal charges after an investigation revealed the gene therapy treatment used kidney cells, not cartilage cells.
Yoon Jung-min has the details.
The Ministry of Food and Drug Safety has revoked the license for the gene therapy drug Invossa after the manufacturer mislabeled and made false reports on one of its ingredients.
The ministry also decided to push prosecutors to file charges against Invossa's manufacturer Kolon Life Science.
"We have decided to cancel the approval of Invossa as solution 2 of the medication contained kidney cells, not cartilage cells as stated in the data submitted by Kolon Life Science,... and we will file charges against the company for submitting false documents."
Invossa is the world's first gene therapy drug for the most common form of arthritis, which is estimated to affect some 5 million people in South Korea.
Following an investigation of the developer of the drug, Kolon TissueGene, the ministry concluded that subsidiary Kolon Life Science falsely reported ingredients used, did not disclose additional data it discovered on the problem before submitting the drug for approval and failed to provide a scientific cause for the mix-up.
Sales and distribution of Invossa was suspended in April, some two years after it won approval for commercialization. The drug had also been sold in Hong Kong and Macau and was in phase three clinical trials in the U.S. Stock prices for Kolon TissueGene and Kolon Life Science plunged following the announcement Tuesday and trading for both companies was suspended for the day.
It's estimated over 3-thousand people have used Invossa, but none have reported any side effects so far. The ministry says it will closely monitor patients in the country and provide extensive medical checkups and long-term care.
Patients and shareholders of related companies plan to file a lawsuit against Kolon worth millions of U.S. dollars.
The ministry also pledged to bolster its safety management for the entire process of drug distribution in the nation.
Yoon Jung-min, Arirang News.
