Novo Nordisk Reports Results of Refixia (nonacog beta pegol) in Two P-III Studies for Hemophilia B in Children

Shots:

• The two P-III studies include Paradigm5 & 6. Paradigm5 involves assessing of Refixia (40 IU/kg, qw) in 25 children with hemophilia B aged ≤12 yrs. resulted in low bleeding rates with 20% bleed free patients and 64% with no spontaneous bleeds. No children developed inhibitory Ab & no new safety signals are observed
• The P-III Paradigm6 study involves assessing of Refixia in male with FIX ≤2%, prior untreated/with ≤3 EDs to FIX-containing products aged <6 yrs. resulted in low bleeding rates and good bleed resolution with median ABRs of 0.0 for overall, spontaneous and traumatic bleeds + 6.1% patients developed inhibitory Ab
• Refixia (N9-GP) is an extended half-life factor IX molecule for replacement therapy indicated to treat and prevent bleeding in patients with haemophilia B and has received EMA’s approval in Jun’2017

Click here to read full press release/ article | Ref: Novo Nordisk | Image: Novo Nordisk