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Drug Ministry officially revokes Invossa license

July 04,2019
The Ministry of Food and Drug Safety made the final decision Wednesday to revoke the license of gene therapy drug Invossa for falsely labeling and reporting a key ingredient.

The Korean drug authority said in an administrative filing that it would ban the production and sales of Invossa effective next Tuesday.

Although the ministry announced the cancellation in late May after suspending production and sales of Invossa in April, it gave the manufacturer Kolon Life Science a chance to comment on the decision last month as part of the official process.

Invossa was granted approval for commercialization in July 2017 on the basis that it used cartilage-originated basis cells, not kidney cells. Company executives have claimed that they had no idea the kidney cells were present in the drug, only revealing the presence of the cells in early 2019.

In response to the official cancellation, Kolon Life Science responded that it has never attempted to manipulate or hide test results during the approval process and will file an administrative lawsuit against the ministry.

The Korea Exchange will decide next week whether to delist Kolon TissueGene, an affiliate of Kolon Life Science.

By Ko Jun-tae


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