NovoSeven® Resolved 96.5% of Bleeds When Initiated Within One Hour After Bleed Onset in People With Haemophilia A or B With Inhibitors

BAGSVÆRD, Denmark, December 3, 2016 /PRNewswire/ --

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Novo Nordisk today 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.^[1] Efficacy also remained high for bleeds treated after 4 hours.^[1] A subanalysis of the SMART-7™ study, evaluating the efficacy of NovoSeven^® in a real-world setting, was presented today at the 58^th American Society of Haematology (ASH) annual meeting.

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^® (≤1 hour, ˃1‒≤4 hours, ˃4 hours).^[1] Across the three groups, 94.6% of bleeds were resolved while another 4.8% of bleeds were slowed.^[1]

"Clinical guidelines recommend that acute bleeds in people with haemophilia should be treated within two hours of bleed onset," said Dr Gary Benson, SMART-7™ investigator, Northern Ireland Haemophilia Comprehensive Care Centre, Belfast City Hospital, Belfast, UK. "This study has shown that NovoSeven^® has a favourable safety profile and can help people living with haemophilia to address bleeds quickly."  

Efficacy results from this subgroup analysis of SMART-7™ are aligned with previous rFVIIa data.^[2]-[7] Furthermore, no binding antibodies were associated with the room temperature stable formulation of rFVIIa under real-world conditions.

About SMART-7™  

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.^[1]

A total number of 51 participants were enrolled across 14 countries. Participants were aged 1.6-69.5 years (median 22.0 years) with a historical median bleeding rate of one episode per month. The primary objective of the study was to monitor people with haemophilia A or B with inhibitors treated with NovoSeven^® for a decreased therapeutic response.^[1]