Invossa Approval Revoked As Korea Confirms False Data Submission
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.
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Following the long-awaited decision from the US FDA, Kolon TissueGene will resume Phase III clinical trials of the cell and gene therapy for degenerative osteoarthritis TG-C (Invossa) in the US this year.
Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.
A new South Korean law to support and manage the safety of cutting-edge regenerative medicines and biologics has been passed amid hopes these will become a national growth engine, although there are concerns that a further easing of rules could lead to another 'Invossa incident'.