South Korea’s Kolon Life Science said on Wednesday the Ministry of Food and Drug Safety has granted marketing approval to its new gene therapy to treat degenerative knee arthritis.
The drug branded Invossa Care Inj., the country’s first home-grown gene therapy and 29th novel medicine, is indicated to treat moderate knee osteoarthritis in patients who continue to experience pain despite drug or physical therapies.
According to clinical data, patients showed a pain reduction and an increase in everyday activities relying on the use of knee joints at one year after treatment with the injectable drug.
Invossa is a cell and gene therapy that contains autologous chondrocytes with transduction of a TGF-β1 gene, a type of protein that inhibits inflammation and heals wounds.
Gene therapy is a medical intervention based on the modification of the genetic material of living cells, or medical products that contain genetically modified or transduced cells.
Only four gene therapies have so far been approved in the U.S. and Europe, according to the ministry.
Gene therapies are used to treat patients with immunodeficiency disease, genetic disease or cancer. Invossa is the first gene therapy for the treatment of knee osteoarthritis. It is currently in its Phase 3 clinical trial in the U.S.
TissueGene Inc., Maryland-based biopharmaceutical arm of Kolon, has the proprietary right to the therapy. The company is gearing up to go public on the Korea’s secondary Kosdaq market in September.
By Kim Hye-soon
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