Ceprotin, Takeda's rare dz, gives 11 yrs for reexamination
By Lee, Hye-Kyung | translator Choi HeeYoung
22.08.11 06:00:42
Korea's first approved treatment for severe congenital protein C deficiency
The Central Pharmacist Review Board said, Insufficient patients, It's hard to evaluate in 4-6 years
On the 2nd, Takeda's Ceprotin, which was first approved as a treatment for severe congenital protein C deficiency in Korea, was given an 11-year review period after marketing. Severe congenital protein C deficiency is a rare genetic disease that causes fatal defects in blood clot control due to a lack of protein C, a type of vitamin K-dependent anticoagulant, and is defined when protein C levels are less than 1% (less than 1 IU/dL), and the incidence rate is estimated to be 1 in 4 million newborns. Ceprotin is the first human protein C drug approved for patients with severe congenital C protein deficiency and was approved for "prevention and treatment of venous thrombosis and fulminant purple hemiplegia in patients wi
Lee, Hye-Kyung(hgrace7@dailypharm.com)