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

Nachrichtenquelle: globenewswire
13.07.2020, 07:03  |  153   |   |   
  • 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 identified1,2,3
  • STASEY is the largest open-label study primarily assessing safety and tolerability of a medicine for haemophilia A with factor VIII inhibitors
  • A 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.

“These important safety data continue to add to the extensive clinical evidence reinforcing Hemlibra’s potential to redefine the standard of care for people with haemophilia A,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “The STASEY study reflects our continued focus on providing valuable insights that meet the needs of the haemophilia community and enhance our understanding of Hemlibra in clinical practice.”

The second interim analysis of the STASEY study included data from 193 patients with haemophilia A with factor VIII inhibitors, who received Hemlibra prophylaxis once-weekly.1 No cases of thrombotic microangiopathy or serious thrombotic events (TEs) related to Hemlibra were reported, and no new safety signals were observed.1 Thirty-three (17.1%) people reported a Hemlibra-related adverse event (AE).1 The most common AEs, occurring in 10% or more of people in the STASEY study, were common cold symptom nasopharyngitis (12.4%), headache (11.9%) and injection-site reaction (ISR) (11.4%).1 The ISRs reported were either mild or moderate in severity and no patients discontinued due to ISR.1 Annualised bleed rates (ABR) were also consistent with previously reported observations from the phase III HAVEN studies.1,2,3

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