Tags : Hemlibra

Roche Reports Updated Results of Hemlibra (emicizumab) in P-III HAVEN

Shots: The P-III HAVEN (1,2,3, & 4) studies involve assessing of Hemlibra in patients with hemophilia A with/out factor VIII inhibitors resulted in zero treat bleeds @83wks., 87% with no treated joint bleeds, 92% with no spontaneous bleeds @25wks., improvement in QoL The P-IIIb STASEY study reinforces safety profile of Hemlibra in 88 patients with […]Read More

Insights+: Breakthrough Therapy Designation by the US FDA in 2018

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to the drugs as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available therapies […]Read More

Roche’s Hemlibra P-III Positive results for Haemophilia A without factor

Shots: The data contains HAVEN 3 (N=152) study evaluating Hemlibra (emicizumab) prophylaxis vs no prophylaxis with patients aged ≥12 yrs HAVEN 3 results: (reduction in treated bleeds 96%/qw, 97%/q2w); (zero treated bleeds 55.6%/qw, 60%q2w); (three or fewer treated bleeds 91.7%qw, 94.3%q2w); (reduction in treated target-joint bleeds 95%) The US granted Hemlibra BT&PR designations for people […]Read More