Study shows NovoSeven (rFVIIa) resolves majority of bleeds in haemophilia A or B- Novo Nordisk

Novo Nordisk has announced that NovoSeven (rFVIIa), a portable room temperature stable recombinant activated factor VIIa, resolved 96.5% of bleeds when initiated within one hour after onset of bleeding, demonstrating efficacy of early treatment in people with haemophilia A or B with inhibitors. Efficacy also remained high for bleeds treated after 4 hours. The SMART-7 study examined the status of bleeding episodes across people with haemophilia divided into three groups by time to first treatment with NovoSeven (less than 1 hour, between 1 and 4 hours, longer than 4 hours).

Across the three groups, 94.6% of bleeds were resolved while another 4.8% of bleeds were slowed. Efficacy results from this subgroup analysis of SMART-7 are aligned with previous rFVIIa data. Furthermore, no binding antibodies were associated with the room temperature stable formulation of rFVIIa under real-world conditions. A subanalysis of the SMART-7 study, evaluating the efficacy of NovoSeven in a real-world setting, was presented at the 58th American Society of Haematology (ASH) annual meeting.

Comment: SMART-7 (NCT01220141) was a prospective, post-authorisation, single-arm, multinational, multi-centre, non-interventional study investigating the safety and effectiveness of NovoSeven (rFVIIa), a room temperature stable recombinant activated factor VIIa in people with haemophilia A or B with inhibitors in a real-world setting.