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