Drug safety minister apologize for Invossa fiasco

By Bahk Eun-ji

The head of the drug safety authority apologized Wednesday for the mishandling of gene therapy drug Invossa, the license of which was recently cancelled following the drug manufacturer's false reporting on an ingredient change.

“I apologize for causing confusion and concern to the public over the problems in the authorization process of Invossa,” Minister of Food and Drug Safety Lee Eui-kyung said during a press briefing in Seoul.

“The government is in talks with the manufacturer of the drug, Kolon Life Science, to compensate patients who used it if they experience side effects,” she said. “We'll do our best to set up safety measures for the patients and prevent such mishandling from recurring again.”

Invossa, the osteoarthritis gene therapy drug for patients with the degenerative joint disease, was approved by the drug safety ministry for its use in Korea in July 2017. The approval was made on the basis that the drug used cartilage-originated cells, but Kolon instead produced and sold the drug made with a different material ― cells originating from the kidney.

Lee said the ministry and Kolon will conduct long-term follow-up health checks for 15 years on all patients who took the drug in case they experience side effects. None have been reported so far, according to the ministry.

A total of 438 hospitals and clinics across the country administered Invossa to 3,707 patients before the treatment suspension, and 1,300 people have registered for the checkups so far, the ministry said.

“From Kolon Life Science, we'll receive a long-term plan by June 14, and will discuss details, scheduling and compensation,” Lee said.

Kolon will be obliged to check the patients' conditions regularly and submit reports to the ministry. To secure reliability and transparency of the checkups, a ministry affiliate, the Korea Institute of Drug Safety and Risk Management, will take part in them, with Kolon paying for this.

The health authorities cancelled the license for Invossa last month after an investigation revealed the company falsely reported the ingredients, and intentionally did not disclose additional data on the problem before the drug's approval. Kolon suspended the sales of Invossa in late March following a ministry directive after it belatedly reported the ingredient change to the ministry.