Note: The following is an excerpt from a press release from Genentech. Read the full press release here.
Given the recent dialogue, we are reaching out to clarify the facts surrounding five people withÂ hemophilia A with inhibitors to factor VIII who have passed away while receiving Hemlibra®Â (emicizumab-kxwh).
Since 2016, five adults with hemophilia A with inhibitors taking Hemlibra have passed away. One of theÂ patients was enrolled in the HAVEN 1 clinical trial; one was in the U.S. expanded access program andÂ three were receiving treatment through compassionate use requests. In each of these cases, the assessmentÂ of the treating physician or investigator was that the cause of death was unrelated to Hemlibra. Based onÂ these assessments and the available information, these events do not change the currently knownÂ benefit/risk profile.