The Hemophilia Federation of America, or HFA, and the National Hemophilia Foundation said Roche Holding AG unit Genentech Inc. informed them of five deaths of patients using its hemophilia A drug Hemlibra.
Although Genentech did not provide much information, the company noted that the patients had received Hemlibra, also known as emicizumab or ACE910, as part of compassionate use and expanded patient access, HFA said.
HFA, an advocacy organization for rare bleeding disorders, on Feb. 22 disclosed a patient death from the phase 3 Haven 1 study of Hemlibra. "Because the other 4 deaths have been under expanded patient access, or compassionate use, there has been little communication available from Genentech," the HFA said in a statement.
In an email to S&P Global Market Intelligence, Roche confirmed the five patient deaths but noted they were unrelated to the treatment. The company said if any adverse event impacts the overall benefit/risk profile of the medicine, it will share that information as quickly as possible.