Posted by Michael Wonder on 04 Jul 2018
CHMP recommends EU marketing authorisation for Veyvondi [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease
2 July 2018 - Veyvondi is currently only approved in the US for adults with VWD.
Shire announced today that the CHMP of the EMA has issued a positive opinion recommending the granting of marketing authorisation in the European Union (EU) for Veyvondi [vonicog alfa, recombinant von Willebrand factor], for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults (age 18 and older) with von Willebrand disease when desmopressin treatment alone is ineffective or not indicated.
Veyvondi should not be used in the treatment of haemophilia A.
If approved, Veyvondi will be the first and only recombinant von Willebrand factor treatment in the EU for von Willebrand disease that specifically addresses the primary deficiency or dysfunction of von Willebrand factor while also allowing the body to restore and maintain adequate factor VIII plasma levels.
