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S. Korea Finalizes Permit Cancellation for Gene Therapy Drug Invossa

Written: 2019-07-03 13:39:12Updated: 2019-07-03 13:50:07

S. Korea Finalizes Permit Cancellation for Gene Therapy Drug Invossa

Photo : KBS News

South Korea's drug authorities revoked a state permit for a gene therapy drug after its manufacturer was found to have falsely reported and mislabeled one of its ingredients.

According to the Ministry of Food and Drug Safety on Wednesday, the decision was made to ban production and sales of Kolon Life Science's Invossa starting next Tuesday.

The ministry previously canceled the license for the drug and filed a complaint with the prosecution against company CEO Lee Woo-sok on charges of violating pharmaceutical laws in late May.

Authorities found that a material used in the osteoarthritis treatment drug, which obtained state approval in 2017, came from a kidney cell instead of from cartilage as stated in the document submitted for approval.

There are concerns that the kidney cell source could cause tumors.

While Kolon Life Science admitted it had mislabeled the drug as early as 2003, authorities also believe its affiliate, Kolon TissueGene, intentionally concealed detection of the kidney cell input before getting the drug's approval.

Kolon Life Science, meanwhile, plans to take legal steps against the ministry, including administrative litigation.

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