There has been a flurry of reports from South Korean news outlets relating to the Invossa GP-293 cell mislabeling incident, and this article is meant to be a summary of those reports.
Kolon Life Science is being sued
Oh Kims Law & Company has started a class action lawsuit against Kolon Life Sciences over injections of Invossa-K, seeking to return the cost of the treatment ( ~$4,400 USD ), plus additional compensation for mental harm, and any other harm incurred. The law firm cited that the company has violated the Pharmaceutical Affairs act, which states “no one shall sell drugs which are licensed but whose ingredients are different from contents as licensed or reported.”
So far, we have not heard of any physical harm from the use of Invossa. The drug had an excellent safety profile in the clinical trials. It appears that the mental harm aspect of the lawsuit is centered around patients’ anxiety as to whether they will have negative effects in the future or not.
Kolon Life Science confirms all formulations of Invossa contained GP-293 cells
Kolon Life Science said all of the cells used for manufacturing Invossa – master cell bank, working cell bank, etc – were found to contain GP2-293 cells derived from the kidney cells, not cartilage cells, as claimed.
Previously, the company stated that this may be an oversight, as the drug has been under development for 19 years, and the Short Tandem Repeat test to identify the cells’ lineage was not commonly used in the early 2000’s when Invossa development began.
It is still unclear as to how or why this fact was omitted. Some industry groups within South Korea are making public statements alleging that Kolon Life Sciences fabricated or omitted data as a means of getting the drug approved. Industry critics are also accusing the South Korean Ministry of Food and Drug Safety of neglecting their duty to properly scrutinize new therapies.
Whether GP2-293 cells in the treatment are harmful or not has yet to be established, but critics claim that no therapy should have been approved with these cells present.
Director of KCR Biologics Registry claims that Invossa was not effective enough to be approved
Shin Ki-chul, director of KCR Biologics Registry and a professor at SMG-SNU Boramae Medical Center, said phase-1 to phase-3 trials on Inovssa did not have proper efficacy parameters and the drug’s efficacy was relatively low.
Shin claims that recently approved tanezumab by Pfizer and Lilly has produced better results for sufferers of knee pain; however we believe that this is a false comparison, because tanezumab addresses inflammation, not the progressive loss of cartilage seen in osteoarthritis. Invossa addresses the progressive loss of cartilage and showed small amounts of cartilage growth in cartilage in phase 1/2 trials. Any reduction of inflammation with Invossa is said to be a side effect of it’s structure modifying effects. Invossa is also dosed as a single injection once a year, whereas tanezumab is a pharmaceutical drug that must be taken perpetually.
Trials of Tanezumab were once halted for worsening osteoarthritis, when reports of bone necrosis and progressive loss of cartilage rolled in. Tanezumab also carries a risk for many serious and potentially deadly side effects, whereas the only side effects found for Invossa thus far are temporary irritation/pain at the injection site – which is typical for any injection into the knee. Tanezumab’s negative effects are also typical for drugs that address the pain/inflammation aspect of arthritis – recent studies have shown that even common NSAIDs can accelerate the loss of cartilage in OA patients by inhibiting cartilage repair.
We find it disheartening to hear that Invossa is facing a multi pronged over cells whose long term effects are unknown. However, KLS has brought the criticism on themselves by mislabeling their ingredients for almost 2 decades.
Regulatory status is still up in the air, and if the Korean FDA rejects Invossa’s approval, it could mean an end to Kolon Life Sciences. We hope the truth is sorted out soon, because without the availability of regenerative medicine like Invossa, those suffering of painful knee arthritis will continue to face symptom-based therapies and non-biocompatible joint replacements as their disease progresses.
Kolon Life Sciences confirms that all cells used for manufacturing Invossa were found to have GP 293 cells: http://www.koreabiomed.com/news/articleView.html?idxno=5555
Invossa lacked clinical evidence to be commercialized: http://www.koreabiomed.com/news/articleView.html?idxno=5578
Kolon to face lawsuit over mislabeling: https://www.koreatimes.co.kr/www/tech/2019/04/694_267407.html