'Ingredient Controversy' Kolon Invossa, Clinical Trial Suspension Lifted in the US

Lee Woo-seok, CEO of Kolon Life Science, who is suspected of being involved in the controversy surrounding the osteoarthritis gene therapy drug 'Invossa K Injection (Invossa)', is attending the pre-arrest detention hearing at the Seoul Central District Court in Seocho-gu, Seoul on January 31. Photo by Moon Ho-nam munonam@

[Asia Economy Reporter Choi Dae-yeol] The U.S. pharmaceutical regulatory authority has decided to reapprove the clinical trials of Kolon Life Science's gene therapy for osteoarthritis, 'Invossa.' Previously, the clinical trials were halted due to controversy over the components, but this suspension has now been lifted.

According to Kolon on the 12th, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on Invossa's Phase 3 clinical trial in the U.S. yesterday and allowed the resumption of the Phase 3 trial involving patient administration. The FDA sent an official letter containing this information to Kolon TissueGene, a subsidiary of Kolon Life Science responsible for development and approval tasks in the U.S. The FDA stated, "All clinical hold issues have been satisfactorily resolved," and added, "You may proceed with the clinical trial."

With this measure, Kolon TissueGene can resume clinical trials 11 months after the FDA's clinical hold decision on Invossa in May last year. The exact date for resumption has not yet been determined. The company explained, "This means that the FDA has recognized the validity of the clinical trial data submitted by Kolon TissueGene so far and has acknowledged that the Phase 3 clinical trial, including patient administration using the genetically transformed kidney-derived cells (Invossa 2), can continue based on this."

Invossa's marketing authorization was canceled in Korea in March last year after it was revealed that the actual drug components differed from those stated in the approval documents. The ongoing Phase 3 clinical trial in the U.S. was halted at that time. In May last year, the FDA decided to place a clinical hold on Invossa's U.S. Phase 3 trial and requested submission of analyses on the characteristics of Invossa's components, the circumstances leading to component changes, and future measures. Additional supplementary materials were requested in September of the same year.

The FDA additionally requested data on improvements to Invossa's manufacturing process and the stability of clinical samples submitted in the annual report. A company official stated, "This request is unrelated to the lifting of the clinical hold and is something that can be sufficiently addressed."

Following consultations with the FDA, Kolon TissueGene plans to proceed with patient administration in the clinical trial once the supplementary procedures for the clinical trial protocol and patient consent documents are completed. There is also interest in whether the resumption of clinical trials in the U.S. might affect ongoing administrative lawsuits in Korea. After the Ministry of Food and Drug Safety canceled Invossa's marketing authorization and filed a criminal complaint, Kolon Life Science, the domestic marketing authorization holder, filed an administrative lawsuit seeking cancellation of the disposition, which is currently ongoing.

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