Kolon Life Science has announced that it has received an approval to continue Invossa-K’s phase-3 clinical trial by the U.S. Food and Drug Administration. Invossa-K is a gene therapy for osteoarthritis and the trial is being run in the United States. 

Apparently, the FDA gave its approval for the drug test nearly a year after it had suspended the study. The Korean regulator had revoked the Invossa license on account of an ingredient mislabeling. The latest decision made by the FDA has given Kolon a fresh start concerning the Invossa business.

The FDA had sent an official notice to a Kolon Life Science subsidiary, Kolon TissueGene, that it will be removing the clinical hold on the Invossa’s phase 3 trial. As per the Kolon TissueGene, the FDA stated that the issues regarding the clinical hold had been resolved and the firm will be able to continue with the Invossa clinical trial.

Kolon had initiated Invossa’s phase-3 study on October 30 in 2018 in the U.S., which was later suspended by the FDA in 2019. The firm had admitted that the cell ingredient that came from the second fluid of the drug had not been derived from the cartilage but the kidney, which is also called GP2-293. The company had submitted the extra data twice for clearance from the regulatory body.

According to sources familiar with the matter, the FDA had requested the firm to submit supplementary materials that also include the ingredients of Invossa like the evaluation of the cell’s identity covering the way the drug composition has changed and the forthcoming measures. The regulator had demanded for analysis of the properties of Invossa ingredients.

The FDA has asked the firm to submit data placed on the stability of all the clinical samples as well as the improvement measures for the production process of Invossa.

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