A Glimpse Of Light For Kolon As US Invossa Trials To Resume
FDA Lifts Clinical Hold
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.
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Novartis has added an anti-osteoarthritic Nanobody, M6495, to its growing pipeline of candidates for the condition, in a €450m agreement with Merck KGaA that sees the latter deliver on its plans to find new homes for its osteoarthritis pipeline.
Kolon TissueGene is facing delisting in South Korea after the recent revocation of approval of gene therapy Invossa, which could fuel legal action from shareholders. The company still hopes to resume Invossa trials in the US by submitting additional data demanded by the FDA.
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.