Pfizer's Benefix was approved as a prophylactic treatment

Routine prevention therapy for hemophilia B patients

Pfizer Korea (CEO Dong-wook Oh) ​​announced on the 22nd that Benefix (Recombinant Blood Coagulation Factor Ⅸ), a hemophilia B treatment, was additionally approved by the MFDS for an indication for routine preventive therapy administered once a week.

 

For those over 12 years of age who are injecting Benefix, a dose of 100 IU/kg once a week is recommended to prevent long-term bleeding, and the dosage should be adjusted according to the patient's clinical response.

 

Benefix is ​​the first factor IX genetically modified hemophilia treatment that has been used for over 20 years for supplemental and prophylactic treatment of pediatric and adult hemophilia patients.

 

Benefix can be injected according to the patient's characteristics and circumstances, including 3000 IU/kg.

 

Not only the average dose of 40 IU/kg (in the range of 13 to 78 IU/kg) in clinical trials for conventional secondary prevention is administered every 3 to 4 days, as well as 100 IU/kg once a week.

 

It is now possible to provide patients with a variety of treatment options.

 

Previously, Pfizer confirmed the efficacy and safety of once-a-week prophylaxis in the Benefix 100IU/kg group through a clinical phase 3 extension study of the once-weekly administration for patients with severe hemophilia B, aged 12 to 65 years.

 

The annual bleeding rate (ABR) was reduced by 94% compared to supplemental therapy, and nearly half (48%) of patients did not experience spontaneous bleeding.

 

The median of the annual bleeding rate, including joint, muscle, and soft tissue bleeding, which hemophilia patients frequently experience during the weekly prophylaxis period, was 0.

 

Even about one week after Benefix administration, blood levels exceeding the required baseline 2IU/dL were maintained (2.13-10.39IU/dL) in most patients (2.13-10.39IU/dL), resulting in a prolonged half-life.

 

For the safety profile, no antibody production and allergic reactions, including the formation of blood clots due to high-dose administration, occurred in a study in which prophylaxis was performed once a week for 12 months.

 

Jo Yeon-jin, executive director of Pfizer's Rare Disease Division said, "Benefix, which has been used for the past 20 years, has a variety of treatment options, including once a week for preventive therapy indications, and we are able to provide customized treatment for patients with hemophilia factor IX."