GC Green Cross announced on the 11th that its severe Hunter syndrome treatment ‘Hunterase ICV’ has received product approval from the Russian Federal Ministry of Health.
This is the first product approval for a severe Hunter syndrome treatment in Russia. Green Cross obtained product approval for Hunterase ICV, the world's first intraventricular severe Hunter syndrome treatment, in Japan in 2021. With this approval, Russia becomes the second country in the world to grant product approval.
Hunter syndrome is a congenital rare disease that results from a deficiency of the I2S enzyme, causing skeletal abnormalities and cognitive decline. It is known to occur in 1 in every 100,000 to 150,000 boys. ‘Hunterase ICV’ is the only treatment method in the world that directly administers the drug into the ventricles using a device implanted in the head, improving central nervous system symptoms. The drug delivered to the patient's cerebral blood vessels and central nervous system cells alleviates symptoms caused by central nervous system damage, such as cognitive ability loss and delays in psychomotor development.
The proportion of severe patients with central nervous system damage among Hunter syndrome patients worldwide is about 70%. Hunterase ICV is also undergoing Phase 1 clinical trials domestically.
Lee Jae-woo, head of development, who led this product approval, noted, “The intravenous form of Hunterase IV already received product approval in 2018 and has been sold to date. With the approval of Hunterase ICV, we can now provide new treatment options to severe Hunter syndrome patients with significant unmet medical needs.”