Court rejects Kolon's petition on gene therapy drug Invossa
Published : Aug 13, 2019 - 20:33
Updated : Aug 13, 2019 - 20:33
A Seoul court on Tuesday turned down a request by Kolon Life Science to suspend the government's decision to prohibit the production and sale of its gene therapy drug Invossa.
The firm initially received approval for the medication from South Korea's Ministry of Food and Drug Safety in 2017. But this was revoked earlier this year after the drugmaker was found to have falsely reported an ingredient used in Invossa and violated labeling rules.
Although Kolon acknowledged that a substance in the joint pain treatment drug had been mislabeled since 2003, it later sought an injunction at the Seoul Administrative Court to halt the ministry's decision. It cited the huge costs incurred from terminating related contracts, legal disputes and loss of investment.
Delivering the ruling, the court pointed out that Invossa's safety has not been fully guaranteed.
It ruled the ministry's measure is justifiable as the original permit was based on false reporting of a key ingredient.
The court added that it is hard to accept the company's assertion that the ministry's actions resulted in unreasonable costs.
In applying for the ministry's approval for Invossa, Kolon wrote in a document that a material used stemmed from cartilage, but it actually came from a kidney cell, according to the ministry. (Yonhap)
Dec 7, 2019