Five patients have died since 2016 while being treated with emicizumab-kxwh for hemophilia A, according to the manufacturer.
The two most recent deaths, in addition to one in 2016 and one in 2017, occurred when patients received emicizumab-kxwh (Hemlibra, Genentech) as part of compassionate use and expanded patient access. The treating physicians’ assessments indicated the cause of death was unrelated to emicizumab-kxwh, according to a statement from Genentech.
One patient death — reported last year — occurred during the HAVEN 1 trial of emicizumab-kxwh. The cause of death, rectal hemorrhage, was deemed unrelated to treatment.
Emicizumab-kxwh is a first-in-class therapy that is given via a weekly subcutaneous injection for bleeding prophylaxis for patients with hemophilia A who have developed factor VIII inhibitors.
“We were deeply saddened to learn about these patients who passed away and take all reports of safety events very seriously. For each report, we followed our safety assessment and reporting processes to ensure prompt evaluation of the event and continued broader patient safety,” Genentech said in a statement. “We are committed to providing timely and transparent updates on Hemlibra’s safety to health authorities, health care professionals and the hemophilia community. If any adverse event in a person taking Hemlibra impacts the overall benefit/risk profile of the medicine, we will share this information as quickly as possible.”
Genentech has a Medical Communications line available for clinicians and patients for more information: 1(800)-821-8590.
“Patient safety is of the highest importance to us, which is why we have systems and processes in place to monitor the safety of all our medicines, including Hemlibra, on an ongoing basis,” Genentech said.
Editors Note: This article was updated to add Genentech’s statement.