Shire Receives EU's MAA for VEYVONDI for the Treatment of von Willebrand disease in adults
Shots:
- Approval is based on three clinical trials (N=80) assessing safety- tolerability- PK- haemostatic efficacy of rVWF in adults: P-III for rFVIII with severe VWD; P-III for rFVIII and rVWF in the treatment of bleeding episodes with severe VWD; P-III with severe VWD undergoing major/ minor/oral elective surgical procedures (w/o rFVIII)
- VEYVONDI [vonicog alfa- recombinant von Willebrand factor] novel rVWF treatment for VWD in EU and for treating haemorrhage and treat surgical bleeding in adults. It can’t be used to treat Haemophilia A
- VEYVONDI will now be marketed in 28 Member States of the EU (Incl. Iceland- Lichtenstein and Norway) and is available in the US as VONVENDI [von Willebrand factor (Recombinant)] for VWD
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