Bayer’s BAY94-9027 Receives CHMP Approval for the Treatment of Haemophilia A aged ≥12yrs.

Bayer Signs an Exclusive License Agreement with Kyoto University for Pulmonary Disorders


  • The CHMP of EMA approval is based on P-II/III PROTECT VIII trial assessing BAY94-9027 in patients ≥12 years treated previously with severe haemophilia A, (74% receiving BAY94-9027 qw) and (100% receiving BAY94-9027 q5day), evaluating its safety and efficacy
  • P-II/III PROTECT VIII Results: mABR (annualised bleed rate) for qw 0.96; half of them with zero bleeds; well tolerated with no new safety issues
  • BAY94-9027 is a recombinant Factor VIII (rFVIII) replacement therapy, which can extend the blood’s ability to coagulate for longer period. Additionally, BAY94-9027 received FDA approval on 30 Aug, 2018 and marketed under the name Jivi

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