Deaths in patients on emicizumab

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Two hemophilia organizations have notified the public of 5 deaths in adult patients receiving emicizumab (Hemlibra).

All 5 deaths—occurring in 2016 (n=1), 2017 (n=2), and this year (n=2)—were deemed unrelated to emicizumab by the investigator or treating physician.

The National Hemophilia Foundation and Hemophilia Federation of America reported these deaths after receiving notifications from Genentech.

The company said it has limited information about the circumstances of the deaths.

However, Genentech did say the 2016 death, 1 of the 2017 deaths, and 1 of the 2018 deaths occurred in patients receiving emicizumab via a compassionate use program.

Compassionate use of emicizumab has been available on a case-by-case basis, following a request to Roche from a patient’s treating physician, if the patient has a serious or life-threatening condition, has exhausted all other treatment options, and is unable to participate in a clinical trial.

The other death in 2017 occurred in a patient on the phase 3 HAVEN 1 trial and was reported along with the other results from that trial.

The remaining death in 2018 was in a patient receiving emicizumab via an expanded access protocol.

This protocol, which was reviewed by the US Food and Drug Administration, allowed US patients who were not participating in a clinical trial of emicizumab but who met eligibility criteria similar to key studies to have access to emicizumab prior to approval, which occurred in November 2017.

In response to the deaths, Genentech has pledged to share information on any adverse events that impact the overall benefit/risk profile of emicizumab.

“We are committed to providing timely and transparent updates on the safety profile of Hemlibra to health authorities, healthcare professionals, and the hemophilia community,” the company said.

For more information, patients and healthcare providers can call Genentech’s medical communications line at 1-800-821-8590. 

Photo from Business Wire

Two hemophilia organizations have notified the public of 5 deaths in adult patients receiving emicizumab (Hemlibra).

All 5 deaths—occurring in 2016 (n=1), 2017 (n=2), and this year (n=2)—were deemed unrelated to emicizumab by the investigator or treating physician.

The National Hemophilia Foundation and Hemophilia Federation of America reported these deaths after receiving notifications from Genentech.

The company said it has limited information about the circumstances of the deaths.

However, Genentech did say the 2016 death, 1 of the 2017 deaths, and 1 of the 2018 deaths occurred in patients receiving emicizumab via a compassionate use program.

Compassionate use of emicizumab has been available on a case-by-case basis, following a request to Roche from a patient’s treating physician, if the patient has a serious or life-threatening condition, has exhausted all other treatment options, and is unable to participate in a clinical trial.

The other death in 2017 occurred in a patient on the phase 3 HAVEN 1 trial and was reported along with the other results from that trial.

The remaining death in 2018 was in a patient receiving emicizumab via an expanded access protocol.

This protocol, which was reviewed by the US Food and Drug Administration, allowed US patients who were not participating in a clinical trial of emicizumab but who met eligibility criteria similar to key studies to have access to emicizumab prior to approval, which occurred in November 2017.

In response to the deaths, Genentech has pledged to share information on any adverse events that impact the overall benefit/risk profile of emicizumab.

“We are committed to providing timely and transparent updates on the safety profile of Hemlibra to health authorities, healthcare professionals, and the hemophilia community,” the company said.

For more information, patients and healthcare providers can call Genentech’s medical communications line at 1-800-821-8590. 

Photo from Business Wire

Two hemophilia organizations have notified the public of 5 deaths in adult patients receiving emicizumab (Hemlibra).

All 5 deaths—occurring in 2016 (n=1), 2017 (n=2), and this year (n=2)—were deemed unrelated to emicizumab by the investigator or treating physician.

The National Hemophilia Foundation and Hemophilia Federation of America reported these deaths after receiving notifications from Genentech.

The company said it has limited information about the circumstances of the deaths.

However, Genentech did say the 2016 death, 1 of the 2017 deaths, and 1 of the 2018 deaths occurred in patients receiving emicizumab via a compassionate use program.

Compassionate use of emicizumab has been available on a case-by-case basis, following a request to Roche from a patient’s treating physician, if the patient has a serious or life-threatening condition, has exhausted all other treatment options, and is unable to participate in a clinical trial.

The other death in 2017 occurred in a patient on the phase 3 HAVEN 1 trial and was reported along with the other results from that trial.

The remaining death in 2018 was in a patient receiving emicizumab via an expanded access protocol.

This protocol, which was reviewed by the US Food and Drug Administration, allowed US patients who were not participating in a clinical trial of emicizumab but who met eligibility criteria similar to key studies to have access to emicizumab prior to approval, which occurred in November 2017.

In response to the deaths, Genentech has pledged to share information on any adverse events that impact the overall benefit/risk profile of emicizumab.

“We are committed to providing timely and transparent updates on the safety profile of Hemlibra to health authorities, healthcare professionals, and the hemophilia community,” the company said.

For more information, patients and healthcare providers can call Genentech’s medical communications line at 1-800-821-8590.