Govt revokes permit for gene therapy drug Invossa - (The Investor via NewsPoints Desk)

  • South Korea's Ministry of Food and Drug Safety revoked the permit for Kolon Life Science's Invossa for mislabeling and the false reporting of an ingredient used, reported The Investor.

  • The ministry said it made the final decision banning the production and sales of Invossa after it canceled the license for the gene therapy in late May and ordered the suspension of sales in April. The ban officially goes into effect next week.

  • Kolon Life acknowledged that a substance in the joint pain treatment had been mislabeled since 2003.

  • Authorities argued that the company intentionally did not disclose additional data it discovered on the problem before submitting the drug for approval, while state regulators said Kolon Life failed to provide scientific cause for the mix-up.

  • According to the news source, there have so far been no cases of side effects associated with Invossa, but patients who received the treatment will be closely monitored for upwards of 15 years.

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