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Korea Suspends First Approved Gene Therapy Pending Component Discrepancy Probe

 
• By Jung Won Shin

South Korea’s first approved gene therapy has been suspended from sale in the country, while recruitment in an ongoing US Phase III program has been temporarily halted, after findings that an active cell component may differ from the data submitted at the time of approval. While both manufacturer and regulator see no safety risk, results from an official Korean probe are due in mid-April.

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Kolon Life Faces Unexpected Challenges After US Trial Findings • Source: Shutterstock

South Korea’s ministry of food and drug safety (MFDS) has asked Kolon Life Science Inc. to suspend the manufacturing and sale of Invossa (TG-C), the country’s first approved gene therapy, after determining that one of its two main active components may be different to that in the data submitted at the time of approval, apparently due to evolving production and testing technology.

A temporary halt has also been placed on a US Phase III development program by the company as a precautionary...

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