South Korean regulators approved Wednesday the country's first-ever cell-mediated gene therapy for degenerative arthritis Invossa, developed by US-based TissueGene, a wholly-owned subsidiary of Korea's Kolon Group.
Korea's Ministry of Food and Drug Safety has granted approval to Invossa-K Inj., an injectable cell gene therapy for osteoarthritis, a joint disease common among the elderly in which the cartilage that cushions the ends of bones between joints breaks down.
Developed by TissueGene for 19 years, Invossa is a first-in-class drug that treats osteoarthritis of the knee through a single intra-articular injection, according to the firm.
It is a cell-mediated gene therapy, which involves inserting normal genes in place of missing or defective ones into a patient's cells to treat a disease.
According to the Korean Drug Ministry, only four cell gene therapies have been approved worldwide for the treatment of immunodeficiency diseases, genetic disorders and cancer. Invossa is the first cell gene drug to treat osteoarthritis.
Invossa has demonstrated pain relief, increased mobility and improvements in joint structure during clinical trials in Korea and the US, offering a complementary treatment option to patients who would otherwise need surgery, Kolon said.
According to the Korean drugmaker, a single injection of Invossa alleviated the symptoms of around 84 per cent of patients during phase 3 clinical trials in Korea.
During phase 2 clinical trials in the US, 88 per cent of patients treated with Invossa reported improved symptoms for up to two years. The drug is currently undergoing phase 3 trials in the US.
Looking ahead, Kolon Life Science, Kolon's Seoul-based drug development unit in charge of Invossa's sales in Korea, plans to begin mass producing the drug for local sales and market the drug in Korea with its partner Mundipharma Korea.
Kolon-owned TissueGene has also signed a licensing partnership with Japan-based Mitsubishi Tanabe Pharma, which is now working to carry out clinical trials and commercialize the cell gene drug in Japan.
Invossa is the 29th novel therapy developed by a Korean company and approved by the local drug regulator.