FDA reapproves phase 3 clinical trial of Invossa

The US Food and Drug Administration has lifted a clinical hold on the phase 3 trial of Kolon Life Science’s osteoarthritis drug Invossa in the US after a 11-month suspension imposed in May.

According to industry sources on Sunday, the FDA sent an official notice to Kolon TissueGene, the biotech unit of Korea’s pharmaceutical firm Kolon Life Science, to resume the phase 3 trial of its degenerative arthritis treatment drug Invossa in the US.

The official FDA notice said that all issues regarding the suspension of the phase 3 trial of Invossa have been resolved to a satisfactory level and Kolon TissueGene may proceed with the phase 3 trial of Invossa as the suspension on the phase 3 trial has been removed.

Following the FDA’s decision, Kolon will be able to resume the phase 3 clinical trial of Invossa, as the lifting of the ban can be translated that the FDA has acknowledged the efficacy of phase 3 trial data submitted by Kolon, allowing the company to continue the injection of kidney-derived cells to patients.

The phase 3 trial of Kolon’s invossa was halted in May after the FDA found out that Invossa’s cell line had been mislabeled as cartilage-derived, while in fact it was kidney-derived cells with tumorigenicity, a proliferation quality similar to that found in cancerous cells.

By Kim Byung-wook (kbw@heraldcorp.com)