The European Commission (EC) has given the green light to Shire’s haemostatic disorder treatment Veyvondi, which is now set to prevent surgical bleeding in adults with von Willebrand disease (VWD).
Administered as an injection, the drug is now the first and only recombinant von Willbrand Factor (rVWF) treatment approved in the EU that specifically treats the primary deficiency of VWF, one of several types of proteins in the blood that are needed to facilitate proper blood clotting.
Patients with VWD usually are deficient in this protein, and affected individuals have symptoms including nosebleeds, bleeding from the gums and easy bruising. Bleeding from the stomach and intestines can occur but it is less common.
Importantly, Veyvondi allows the body to not only restore adequate VWF levels but maintain them also.
Andreas Busch, head of research and development and chief scientific officer, Shire, 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.”
VWD is the most common inherited bleeding disorder, affecting up to 1% of the global population and 100,000 people in the EU.
Busch added: “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.”
The European Regulator’s decision was based out data from three clinical trials assessing tolerability, pharmacokinetics, safety and efficacy of the drug.
The drug has been approved in the US for more than two years under the brand name Vonvendi, indicated for use in adults diagnosed with VWD for on-demand treatment and control of bleeding episodes or perioperative management of bleeding.