Genentech: Given the recent dialogue, we are reaching out to clarify the facts surrounding five people with hemophilia A with inhibitors to factor VIII who have passed away while receiving Hemlibra® (emicizumab-kxwh).
Since 2016, five adults with hemophilia A with inhibitors taking Hemlibra have passed away.
One of the patients was enrolled in the HAVEN 1 clinical trial; one was in the U.S. expanded access program and three were receiving treatment through compassionate use requests. In each of these cases, the assessment of the treating physician or investigator was that the cause of death was unrelated to Hemlibra.
Based on these assessments and the available information, these events do not change the currently known benefit/risk profile.
March 29, 2018