Shots: The company will present data from the final analysis of P-IIIb STASEY study of Hemlibra (emicizumab) reinforcing the safety & efficacy of Hemlibra in people with hemophilia A with […]readmore
Tags : Hemlibra
Shots: The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period […]readmore
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 […]readmore
Shots: The approval is based on HAVEN 3 & 4 studies. The P-III HAVEN 3 study results assessing Hemlibra (qw/q2w) vs episodic FVIII & no prophylaxis in 152 patients with […]readmore
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 […]readmore
Shots: The approval is based on P-III HAVEN 3 & HAVEN 4 study assessing Hemlibra in 152 & 48 patients haemophilia A without & with/without factor VIII inhibitors aged > […]readmore
Shots: Hemlibra’s approval is based on results of P-III HAVEN 3 study assessing Hemlibra qw or q2w vs no prophylaxis and HAVEN 4 study assessing Hemlibra q4w, in patients aged […]readmore
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 […]readmore
Shots: The FDA’s BT designation is based on P-III HAVEN 3 study assessing Hemlibra vs no prophylaxis in 152 patients in ratio (2:2:1) with hemophilia A + prior treated with […]readmore