Maryland-based TissueGene said today that Invossa, which it touts as the world’s first cell and gene therapy for degenerative arthritis, won approval from the Korea Ministry of Food and Drug Safety.
Invossa is designed to treat osteoarthritis of the knee through a single intra-articular injection.
Kolon Life Science (KSDQ:102940), TissueGene’s exclusive licensee for Asia, filed for a biologics license application for the therapy in August 2016 based on results from its Phase III clinical trials.
“We are excited to launch the world’s first cell and gene therapy for knee osteoarthritis and potentially the world’s first disease-modifying osteoarthritis drug,” TissueGene CEO Woosok Lee said in prepared remarks. “This approval is the first critical step towards a global launch for this innovative, novel cell and gene therapy technology that will address one of the most pressing unmet medical need affecting millions of people suffering from osteoarthritis worldwide.”
The company also said that it plans to seek a disease-modifying osteoarthritis drug designation from the FDA, supported by its Phase III clinical trial program in the U.S.