The Minister for Food and Drug Safety on Wednesday apologized for authorizing the use of the gene therapy drug Invossa to treat arthritis. It has since revoked that approval.

“I apologize for failing to thoroughly monitor the approval of Invossa and after-care (for patients),” Drug Safety Minister Lee Eui-kyung said at a press conference, adding that the ministry would do its best to prevent any recurrence and pass measures to keep patients safe.

Earlier the same day, 10 South Korean insurance companies filed suit against the manufacturer, Kolon Life Science, seeking an estimated 30 billion won ($25 million) in damages altogether.

Invossa, a joint inflammation treatment based on gene therapy, had been KLS’ main cash cow drug since the Drug Safety Ministry approved sales in 2017. The ministry revoked that approval May 28 after confirming that KLS had made false declarations on its application for approval to sell the drug, saying it had developed Invossa using a substance derived from cartilage cells, when it actually came from kidney cells.

KLS maintains that it was a “mix-up” and that the company was unaware of the problem for 15 years, ever since the research and development phase began in 2003.

Prior to the ministry’s decision to revoke its approval, Invossa was No. 29 on a chronological list of 30 Korea-made original drugs and had been touted as a success for the Korean biopharma industry. The mislabeling became an issue this year when KLS’ US arm, Kolon TissueGene, sought approval for Invossa from the US Food and Drug Agency in hopes of selling it on the US market.

The Drug Safety Ministry said it would monitor the health status of patients who had taken Invossa for the next 15 years and would also negotiate with Kolon Life Science to see that patients received appropriate compensation. The 15-year follow-up is in line with FDA guidelines for long-term follow-up tests after gene therapy.

KLS is obligated to submit a 15-year plan to the ministry by June 14 showing how it will monitor the progress of patients who received a total of 3,707 Invossa shots at 438 hospitals here. Patients paid 5 million to 8 million won per shot.

The ministry also plans to strengthen its verification standards when approving novel drugs in Korea in the future. Through envisioned amendments to the Pharmaceutical Affairs Act, the ministry hopes to increase penalties for intentional submission of false data in these cases, something KLS denies having done. Currently, the maximum penalty is five years imprisonment or a 50 million won fine.

As of Wednesday, 1,303 people who took Invossa had voluntarily uploaded their data to the Korea Institute of Drug Safety and Risk Management website. Adverse effects from Invossa can be reported to the institute by calling 1644-6223.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)