SEOUL, May 28 (Xinhua) -- South Korea's drug authorities on Tuesday cancelled the approval of a gene therapy drug Invossa for the false reporting of its ingredient.
The Ministry of Food and Drug Safety confirmed that the ingredient used in Invossa, the country's first osteoarthritis gene therapy drug, stemmed from a kidney cell, not from cartilage.
It decided to bring a criminal charge against the local drugmaker Kolon Life Science for submitting a false document on the joints disorder drug to the drug authorities.
The license for Invossa was issued in July 2017 when the drugmaker intentionally concealed possible problems with the drug it discovered before submitting the document for approval, according to the drug authorities.
The cell used in Invossa is known to have the danger of causing cancer. The Kolon Life Science reportedly said there was no concealment and manipulation.
The drug authorities saw no big worry about the side effect of Invossa, of which the kidney cell exists no longer 44 days after administering it.
However, it decided to closely monitor patients, to whom Invossa was administered, for up to 15 years to brace for possible side effects. A total of 438 hospitals and clinics have administered 3,707 doses of the drug nationwide.
According to Yonhap news agency, Invossa was sold to China's Hong Kong Special Administrative Region and China's Macao Special Administrative Region. Kolon Life Science also announced that it signed an export deal in January to Indonesia and Singapore.