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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