First approval of cell and gene therapy for knee osteoarthritis

12 July 2017

What is claimed to be the world's first cell and gene therapy for degenerative arthritis to be cleared for marketing anywhere has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS).

The product in question is USA-based TissueGene’s Invossa-K injection, which is licensed to South Korean firm Kolon Life Science (KS Kosdaq: 102940).

Kolon Life Science filed for a Biologics License Application (BLA) for Invossa-K Inj. with MFDS in August 2016 based on efficacy results from its Phase III clinical trials conducted at 12 major university hospitals in Korea. Invossa-K Inj. will be manufactured by Kolon Life Science, and marketed by Mundipharma and Kolon Pharmaceuticals for the South Korean market.

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