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Home Industry News Shire’s Veyvondi accepted for European regulatory review

Shire’s Veyvondi accepted for European regulatory review

27th June 2017

Shire has announced that its new recombinant von Willebrand factor treatment Veyvondi has been accepted for European regulatory review.

The European Medicines Agency has validated the company's marketing authorisation application for Veyvondi and will now assess the drug as a means of preventing and treating bleeding episodes and perioperative bleeding in adults with von Willebrand disease.

This condition is the most common inherited bleeding disorder and is characterised by an inability of the blood to clot properly, which may result in heavy menstrual periods, easy bruising or frequent nose bleeds.

Veyvondi is the only treatment of its kind and has demonstrated its safety and efficacy in two phase III clinical trials, data from which will be used to support this application.

Dr Alice Dietrich, head of global medical affairs at Shire, said: "Today's submission marks an important milestone in our efforts to address needs of patients living with von Willebrand disease and make Veyvondi available to more patients who could benefit from its use."

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