The P-III (explorer7) study evaluates concizumab in a ratio (1:2) in 7133 males aged ≥12yrs. patients with haemophilia A or B with/out inhibitors
The results showed an 86% reduction in treated spontaneous & traumatic bleeds, mean ABR of 1.7 vs 11.8 with no prophylaxis & overall median ABR was 0 vs 9.8, 63.6% vs 10.5% experienced no treated bleeds. The safety & tolerability profile was within the expected range with no thromboembolic events reported after treatment restart
The company is expected to submit for regulatory approval of concizumab for prophylactic treatment of haemophilia A or B with inhibitors in H2’22 in the US & Japan and 2023 in the EU & the UK. The therapy is also being studied in (explorer10) paediatric study & is expected to be complete in 2026
Ref: GlobeNewswire | Image: Novo Nordisk
