Interim data from the Phase 3 HAVEN 2 study assessing Roche's (OTCQX:RHHBY) Genentech unit's emicizumab for reducing bleeding episodes in children younger than 12 years of age with hemophilia A showed a clinically meaningful treatment effect. The results are consistent with the first Phase 3, HAVEN 1, which showed that prophylactic administration with emicizumab produced a statistically significant reduction in bleeds over time compared to no prophylaxis.
Data from both HAVEN 1 and HAVEN 2 will be presented at an upcoming medical conference. The results will also be submitted with regulatory authorities for approval consideration.
Emicizumab is an bispecific antibody engineered to bind to both factors IXa and X, replacing the function of the missing factor VIII, thereby improving clotting function and preventing spontaneous bleeding. It was created by Chugai Pharmaceutical Co. and is being co-developed by Genentech.
Previously: Genentech's emicizumab successful in late-stage hemophilia A study (Dec. 22, 2016)
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