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Five deaths linked to Roche's haemophilia drug Hemlibra

Published on 28/03/18 at 09:57am

Roche has been rocked by the revelation that there have been five patient deaths linked to the use of its bispecific factor IXa- and factor X-directed antibody Hemlibra (emicizumab-kxwh), sending its shares slipping.

The Hemophilia Federation of America (HFA) announced the news after it said it had been informed of the deaths directly by Roche’s biotech subsidiary Genentech. It means that there have been four more fatalities in addition to the death reported last year.

According to the HFA, Genentech reportedly claimed that it currently has only limited information so far relating to the deaths, but confirmed that patients had received the drug as part of compassionate use and expanded patient access. In a separate statement, the National Hemophilia Association stressed that the events “have all been deemed unrelated to Hemlibra by the investigator or treating physician”.

These claims were corroborated by Roche itself in a statement to Endpoints News. According to the firm, three of the deceased patients had received Hemlibra via compassionate use requests, one was part of an expanded use protocol, and the earliest case was part of the HAVEN III trial investigating the drug’s efficacy.  

While the news may have slightly dented Roche’s momentum in the space, it is unlikely it will stand in the way of realising Hemlibra’s massive forecasted sales, which are expected to hit $4 billion.

Matt Fellows

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