The Ministry of Food and Drug Safety said Wednesday it granted approval to Kolon’s gene therapy for knee osteoarthritis as the 29th domestically produced drug to gain approval and as the first of its kind.
The recently licensed gene therapy is based on chondrocytes derived from cartilage sources that introduced TGF-β1, a type of protein that acts on inflammation inhibition and wound healing.
Invossa is the world’s first allogeneic cell therapy for degenerative arthritis, according to Kolon. The treatment is used to treat patients with moderate (Kellgren & Lawrence grade 3) knee osteoarthritis (OA), marked by persisting pain despite medication and physical therapy. The drug is injected once in the knee joint.
Gene therapy is the transplantation of normal genes into defective cells to correct genetic disorders. Gene therapy products licensed in the U.S. and Europe are used to treat immunodeficiency diseases, genetic diseases, and in chemotherapy.
Researchers have proved the safety and efficacy of Invossa in phase 3 clinical trials, which showed the drug improved pain, daily activities, and cartilage structure in patients with OA, the company said.
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