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Invossa Approval Revoked As Korea Confirms False Data Submission

 
• By Jung Won Shin

In a worst case scenario for the country’s first approved gene therapy, South Korea has cancelled the global-first approval of Kolon Life’s Invossa and asked prosecutors to press criminal charges against the company, which it concluded submitted false data to support approval. The major blow to the company comes as it is already facing lawsuits from patients and investors, and has prompted a broader regulatory overhaul for novel biologic therapies.

MFDS
Korean Regulators Announce Decision On Gene Therapy Invossa • Source: Korea Ministry of Food and Drug Safety

South Korea’s Ministry of Food and Drug Safety (MFDS) has canceled the approval of Kolon Life Science Inc.’s pioneering cell and gene therapy Invossa (TG-C), after it concluded the company submitted false data at the time of approval. The ministry has also asked prosecutors to press criminal charges against the company.

The move, effective 28 May, follows the MFDS’s probe and due diligence into Kolon Life’s US subsidiary Kolon TissueGene, which had been progressing the late-stage clinical development of Invossa in...

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