Shire: VEYVONDI Gets EU Approval To Treat Von Willebrand Disease In Adults

(RTTNews) - Shire plc (SHP.L, SHPG), a biotech company in rare diseases, announced Wednesday that the European Commission or EC has granted Marketing Authorization for VEYVONDI [vonicog alfa, recombinant von Willebrand factor] (rVWF) for adults with von Willebrand disease or VWD.

With this approval, Shire is now authorized to market VEYVONDI in the 28 Member States of the European Union, as well as in Iceland, Lichtenstein and Norway.

VEYVONDI is the first and only recombinant von Willebrand Factor or rVWF to treat hemorrhage and treat/prevent surgical bleeding in adults with VWD, the company noted.

It is the first and only recombinant rVWF treatment in the EU for VWD that specifically addresses the primary deficiency or dysfunction of von Willebrand Factor while also allowing the body to restore and maintain adequate Factor VIII (FVIII) plasma levels.

VEYVONDI should not be used in the treatment of hemophilia A, Shire noted.

The Marketing Authorization is based on outcomes from three clinical trials of a total 80 patients with VWD exposed to VEYVONDI. VWD is caused by a deficiency or dysfunction of VWF, one of several types of proteins in the blood that are needed to facilitate proper blood clotting.