[의학신문·일간보사=김상일 기자]Pfizer Pharmaceutical Korea (CEO Dong-wook Oh) recently announced that’Benefix’ (ingredient name Nonakogalpha), a hemophilia B treatment, has received additional approval from the Ministry of Food and Drug Safety as an indication for routine preventive therapy at a dosage once a week.
According to the new permission, in order to prevent bleeding in the long term, for those over 12 years of age who are taking’Benefix’, a dose of 100 IU/kg once a week is recommended, and the dosage is adjusted according to the clinical response of the patient.
Benefix is the first factor 9 genetically modified hemophilia treatment that has been used for over 20 years for supplemental and prophylactic treatment of pediatric and adult hemophilia patients.
In addition, Benefix offers patients the possibility of flexible dose selection according to their characteristics and circumstances, based on a high-dose option including 3000 IU/kg.
With this permission change, the average dose of 40 IU/kg (in the range of 13-78 IU/kg) in the existing general secondary prevention clinical trial is administered every 3-4 days as well as 100 IU/kg once a week. Prophylaxis has become possible, allowing patients to be given a variety of treatment options.
Korea Pfizer Pharm’s Rare Disease Business Division’s Managing Director Jo Yeon-jin said, “This weekly prophylaxis indication approval has enabled us to provide customized treatment for patients with hemophilia 9th factor.”