The controversy over the safety of Invossa-K, gene therapy for osteoarthritis by Kolon Life Science, has surfaced again after the drug regulator re-notified its 2019 order to recall and discard all Invossa products.

The notification came amid the company’s ongoing legal battles to reverse the Ministry of Food and Drug Safety’s decision to nullify the Invossa permit.

Life Science’s Invossa-K has drawn the pharmaceutical industry’s attention after the drug regulator re-notified the 2019 recall of Invossa.
Life Science’s Invossa-K has drawn the pharmaceutical industry’s attention after the drug regulator re-notified the 2019 recall of Invossa.

The ministry said it re-notified the recall because Kolon Life Science recently withdrew the lawsuit against the regulator’s order to recall and discard Invossa products.

On Thursday, the ministry announced that it re-notified the recall and discard order on all products of Invossa-K as of May 14 on the regulator’s integrated drug information website.

In the notice, the regulator said Invossa received approval even though the main ingredient of the second fluid was not cartilage-derived cells but kidney-derived cells. As Kolon manufactured and sold Invossa products that contained kidney-derived cells posing a risk to public health, the government had to recall the product, it said.

In response, Kolon Life Science, “We had already completed the recall and discarded of Invossa a long time ago.”

As pharmaceutical industry watchers closely followed the re-notification of the Invossa recall, the ministry hurried to clarify the details.

The ministry revised the date of the recall order to July 9, 2019, explaining on the drug information website that the re-notification came after the company’s lawsuit withdrawal.

“During the 2019 Invossa recall, Kolon Life Science filed a suit to stop the ministry recall order. A court recognized Kolon’s request, and we had to remove the recall order,” a ministry official said. “Recently, as Kolon withdrew its lawsuit for the recall nullification and notified the regulator on May 14, we resumed the 2019 order and re-notified it.”

On April 29, Kolon Life Science said in a public filing that it canceled two administrative suits over approval for the phase-3 K&L Grade2 trial plan and the order to recall and discard Invossa, out of the three ongoing administrative lawsuits.

However, it would continue to pursue the administrative suit to reverse the ministry’s decision to nullify the license of Invossa, Kolon Life Science said.

In February, the Seoul Administrative Court turned down Kolon’s appeal for suspending the execution of the order to stop making and selling Invossa.

Kolon Life Science filed an appeal in March and is proceeding with the lawsuit.

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