Today, Kolon Life Sciences ordered an emergency stop-sale on distribution and sales of their pioneering cartilage regeneration drug, Invossa.
KLS CEO Lee Woo-suk held a press conference explaining the reason for the temporary withdrawal – an ingredient in Invossa’s formulation was mislabeled as originating from a chondrocyte cell, instead of a kidney cell.
This discrepancy was recently found when a STR review was performed to prepare for regulatory approval of Invossa in the United States.
The company went on to explain that they have been working on Invossa’s formulation since the early 2000’s, and identifying the origin of certain cells used was not possible with the technology used during the early phases of development.
Lee Woo-suk has stated that there will be delays in business plans, but believes that a change in labeling and working with the Korean Ministry of Food and Drug safety may be sufficient to re-establish approval of the drug.
Invossa is currently in phase 3 clinical trials in the United States, and was approved for use in arthritic patients in 2018 in Korea.
Read the full story: http://www.koreaherald.com/view.php?ud=20190401000631