GC Biopharma¡¯s Hunterase approved after 11yrs
By Chon, Seung-Hyun | translator Kim, Jung-Ju
23.11.16 09:51:37
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Received conditional approval under the condition of conducting a Phase III trial in 2012
Completed phase three trial and received official marketing authorization
GC Biopharma¡¯s rare disease treatment ¡®Hunterase¡¯ was granted official marketing authorization 11 years after receiving conditional approval.
Hunterase, which was approved in 2012 in Korea, is the world¡¯s second treatment for developed Hunter syndrome, which is also known as ¡®Mucopolysaccharidosis type II (MPS II),¡¯ is a rare disease that is known to occur in roughly 1 in 100,000 to 150,000 male live births. As a congenital, hereditary metabolic disorder, Hunter syndrome shows various unpredic
Chon, Seung-Hyun(1000@dailypharm.com)
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