Emicizumab trial death being investigated by Roche

A hemophilia patient has died in a Phase III trial evaluating emicizumab (ACE910), a bi-specific antibody from the Swiss pharma giant Roche (ROG: SIX), it has emerged.

Roche confirmed the news in a statement to the European Hemophilia Consortium, a non-profit organization representing patient groups, but said that an investigator had put the death down to rectal hemorrhage rather than emicizumab.

The company had reported in December 2016 that the HAVEN 1 study of emicizumab prophylaxis in people 12 years of age or older with hemophilia A and factor VIII inhibitors, had met its primary endpoint. At that point it was reported that two patients had thromboembolic events and two developed thrombotic microangiopathy (TMA).