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
Tags : Haemophilia A
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 CHMP of EMA approval is based on P-II/III PROTECT VIII trial assessing BAY94-9027 in patients ≥12 years treated previously with severe haemophilia A, (74% receiving BAY94-9027 qw) and […]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