Patient Death Casts Cloud Over Roche Emicizumab Hemophilia Trial
The death of a patient during the HAVEN 1 study of Roche's investigational hemophilia product, emicizumab, may be nothing to panic about, but it is increasing concerns over its likely impact on the potential blockbuster drug's label.
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News of the deaths, which included patients using Hemlibra for compassionate use and in clinical trials, has put the drug's safety profile in the spotlight again even though Roche has pointed out investigators have stated that the causes of death were unrelated to the recently-approved hemophilia A therapy.
Japan has become the third major market after the US and EU to approve Chugai’s novel antibody Hemlibra (emicizumab) for hemophilia, adding another building block for what the company hopes will become a major international growth driver, but some uncertainties remain.
Roche's Genentech reported positive top-line Phase III results for Hemlibra in a second hemophilia A population – patients without inhibitors – just four days after its approval for patients with inhibitors, which will broaden the product's market and may improve its competitive position.