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New data from phase IIIb study reinforces safety profile of Roche’s Hemlibra in people with haemophilia A

Written by Customer Service on . Posted in Public Companies.

Second interim analysis of the STASEY study, including data from 193 patients, consistent with results from phase III HAVEN studies, with no new safety signals identified1,2,3STASEY is the largest open-label study primarily assessing safety and tolerability of a medicine for haemophilia A with factor VIII inhibitorsA separate analysis also suggests people on Hemlibra may be able to undergo certain minor surgeries without additional preventative coagulation treatment and major surgeries could be managed with additional prophylactic coagulation factor4             
Basel, 13 July 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the second interim analysis of the phase IIIb STASEY study, which reinforce the safety profile of Hemlibra® (emicizumab) characterised in the phase III HAVEN clinical programme.1,2,3 In the STASEY study, Hemlibra was effective with no new safety signals identified in adults and adolescents with haemophilia A with factor VIII inhibitors, which was consistent with previous safety observations.1 Further new interim data suggest that people on Hemlibra may be able to undergo certain minor surgeries without additional preventative (prophylactic) coagulation factor.4 These data were presented at the International Society on Thrombosis and Hemostasis (ISTH) 2020 Virtual Congress, 12-14 July 2020.Attachment13072020_MR_Hemlibra ISTH Stasey Data_EN

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