Shire’s Veyvondi approved by the EC for von Willebrand disease

Von Willebrand disease (VWD) is an inherited haemotastic disorder that affects around 100,000 people in Europe and 1% of people around the world. VWD patients typically bruise easily and suffer from bleeding gums and nosebleeds. Less typical symptoms are bleeding from the intestines and the stomach.
Veyvondi is an injectable drug already approved in the US under the name Vonvendi to control bleeding in adults with VWD. Now the European Commission has considered data from three clinical trials assessing tolerability, safety and efficacy, and pharmacokinetics and approved the drug in the EU to prevent surgical bleeding in adult VWD patients. Veyvondi becomes the only EU approved recombinant von Willebrand Factor (rVWF) treatment for addressing the primary deficiency of VWF, one of a number of proteins in the blood required for blood clotting, and crucially it allows the body to restore and maintain adequate VWF levels.
Shire’s head of research and development and chief scientific officer, Andreas Busch, said: “The approval in Europe for VEYVONDI marks a key milestone in our efforts to tackle unmet medical needs for those living with von Willebrand disease. We are excited to take the next steps in ensuring that Veyvondi is widely available across Europe to address the individual needs of those affected by the condition and in need of factor replacement.”